Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- K250373ProLift Expandable Spacer System2Cleared 510(K)
- K243074Spectrum Spine Lumbar Cage System2Cleared 510(K)
- K250186GoLIF! Lumbar Interbody Fusion System2Cleared 510(K)
- K242771Tesera-k PL System and Tesera-k XL System2Cleared 510(K)
- K241783FortiVy™ OsteoVy™ Lumbar IBF2Cleared 510(K)
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer2Cleared 510(K)
- K243739AxCess® Expandable Interbody System2Cleared 510(K)
- K243668ProLift Pivot Expandable Spacer System2Cleared 510(K)
- K243670Idys® LIF2Cleared 510(K)
- K241073DZ-Tabone Intervertebral Body Fusion Device2Cleared 510(K)
- K242829BluEX Lumbar Expandable Cage System2Cleared 510(K)
- K242589Scarlet® AL-T2Cleared 510(K)
- K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System2Cleared 510(K)
- K242826ProLift Wedge Expandable Spacer System2Cleared 510(K)
- K242267Gemini Medical Cage System2Cleared 510(K)
- K242457EARP Interbody System2Cleared 510(K)
- K242364IdentiTi™ II Interbody System2Cleared 510(K)
- K240889ARTFX Lumbar PEEK Cages2Cleared 510(K)
- K233807LumiVy™ Lumbar IBF System2Cleared 510(K)
- K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System2Cleared 510(K)
- K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device2Cleared 510(K)
- K242509HAnano InterFuse(R) Modular Interbody2Cleared 510(K)
- K2402503D Printed PEEK Interbody System2Cleared 510(K)
- K241438Signus Tetris™ St; Signus Tetris™ R St2Cleared 510(K)
- K241164IB3D™ PL Spinal System2Cleared 510(K)
- K234035COSINE™ Spacer2Cleared 510(K)
- K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)2Cleared 510(K)
- K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology2Cleared 510(K)
- K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)2Cleared 510(K)
- K240326Solar™ Lumbar Interbody Fusion System2Cleared 510(K)
- K241413sagAlign Lumbar Cage System (Various PNs)2Cleared 510(K)
- K234077SPIRA® Anterior Lumbar Spacers2Cleared 510(K)
- K241019aprevo® TLIF-C Articulating System2Cleared 510(K)
- K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System2Cleared 510(K)
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System2Cleared 510(K)
- K240749PILLAR SA Ti Spacer System (82-XXX)2Cleared 510(K)
- K240566Reef L Interbody System; WaveForm L Interbody System2Cleared 510(K)
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System2Cleared 510(K)
- K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)2Cleared 510(K)
- K234150Lucent® XP2Cleared 510(K)
- K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device2Cleared 510(K)
- K233375Tranquil-L Interbody System2Cleared 510(K)
- K233075“BioGend” Interbody Fusion System 001 Cage2Cleared 510(K)
- K234087restor3d TIDAL Lumbar Interbody Fusion System2Cleared 510(K)
- K233744Curiteva Porous PEEK Lumbar Interbody Fusion System2Cleared 510(K)
- K233694Meridian Interbody System; WaveForm A Interbody System2Cleared 510(K)
- K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System2Cleared 510(K)
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System2Cleared 510(K)
- K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System2Cleared 510(K)
- K232069Expandable Lumbar Fusion Cage (Type I,Type II)2Cleared 510(K)
- K232292Peridot-EX Expandable Intervertebral Body Fusion System2Cleared 510(K)
- K232504Calibrate CCX Interbody System2Cleared 510(K)
- K232014CONDUIT™ ATP Inserters2Cleared 510(K)
- K231680AccelFix Lumbar Expandable Cage System2Cleared 510(K)
- K221894Lumbar Expandable lnterbody Spacers -Additional Indications/Implants2Cleared 510(K)
- K231275Exceed™ Biplanar Expandable Interbody System2Cleared 510(K)
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System2Cleared 510(K)
- K231241NanoHive Medical Lumbar Interbody System2Cleared 510(K)
- K230942SPIRA® Posterior Lumbar Spacers2Cleared 510(K)
- K231252Ventana™ L Spinal System2Cleared 510(K)
- K231199Solar Lumbar Interbody Fusion System2Cleared 510(K)
- K231359RODIN™ Expandable Lumbar Cage System2Cleared 510(K)
- K230851Kodiak Lumbar Spacer System2Cleared 510(K)
- K231140aprevo® transforaminal lumbar interbody fusion device2Cleared 510(K)
- K230219Eminent Spine 3D Lumbar Interbody Fusion Systems2Cleared 510(K)
- K223335SIRION Lateral Lumbar Interbody System2Cleared 510(K)
- K223430ProLift Micro Expandable Spacer System2Cleared 510(K)
- K223868PYXIS 3D Titanium Cage System2Cleared 510(K)
- K223611Calibrate LTX Interbody System2Cleared 510(K)
- K223418DeGen Impulse AM™ System2Cleared 510(K)
- K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments2Cleared 510(K)
- K223776PEEK Spinal Infusion Cage2Cleared 510(K)
- K223174X-Pac Expandable LLIF Cage System2Cleared 510(K)
- K223474PathLoc-TA Expandable Lumbar Cage System2Cleared 510(K)
- K223412LumiVy™ Lumbar IBF System2Cleared 510(K)
- K223671CONDUIT LLIF Straight Inserters2Cleared 510(K)
- K223654Medussa-PL Cage2Cleared 510(K)
- K2136534CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM2Cleared 510(K)
- K223251Hexanium PLIF2Cleared 510(K)
- K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology2Cleared 510(K)
- K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)2Cleared 510(K)
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate System2Cleared 510(K)
- K222455Calibrate LTX Interbody System2Cleared 510(K)
- K222732WaveForm A Interbody System2Cleared 510(K)
- K221719ABTross ALIF Expandable Cage System2Cleared 510(K)
- K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices2Cleared 510(K)
- K222203DualXSLIM(R) T/PLIF2Cleared 510(K)
- K222797X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K221858ZSFab Lumbar Interbody System2Cleared 510(K)
- K221172FOCUS Interbody System2Cleared 510(K)
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System2Cleared 510(K)
- K213417Ghost Spacer System2Cleared 510(K)
- K213641MONDRIAN ALIF Cage with Supplementary Fixation Plate2Cleared 510(K)
- K220953ChoiceSpine TigerShark™ M, Modular Interbody System2Cleared 510(K)
- K221325CONDUIT Lateral Switch Plate2Cleared 510(K)
- K221844TDM Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices2Cleared 510(K)
- K221687Pegasus-X Expandable PLIF System2Cleared 510(K)
- K221535Align Lumbar Interbody Fusion System2Cleared 510(K)
- K220449DePuy CONDUIT LLIF SQUID Inserter2Cleared 510(K)
- K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System2Cleared 510(K)
- K220523restor3d TiDAL Lumbar Interbody Fusion Device2Cleared 510(K)
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System2Cleared 510(K)
- K220581Zavation eZspand Interbody System2Cleared 510(K)
- K220902Navagio Lumbar Cage2Cleared 510(K)
- K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System2Cleared 510(K)
- K213420WaveForm L System, WaveForm TO System, WaveForm TA System2Cleared 510(K)
- K212477EARP Interbody System2Cleared 510(K)
- K214010Anteralign Spinal System with Titan nanoLOCK Surface Technology2Cleared 510(K)
- K212811Ti3Z Lumbar Interbody System2Cleared 510(K)
- K213355Toro-L Interbody Fusion System2Cleared 510(K)
- K220655X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K220453FlareHawk Interbody Fusion System2Cleared 510(K)
- K220096Genesys Spine 3DP Lumbar Interbody System2Cleared 510(K)
- K213441PathLoc Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K212930LumiVy Lumbar IBF System2Cleared 510(K)
- K213951FORZA XP Expandable Spacer System2Cleared 510(K)
- K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty2Cleared 510(K)
- K212524Anteralign Spinal System with Titan nanoLOCK Surface Technology2Cleared 510(K)
- K212075ShurFit Lumbar Interbody System2Cleared 510(K)
- K212050NGM WAVE PLIF Cage2Cleared 510(K)
- K212653Catalyft LS Expandable Interbody System2Cleared 510(K)
- K211845Deploy Expandable Interbody System2Cleared 510(K)
- K212823DePuy CONDUIT LLIF Angled Inserters2Cleared 510(K)
- K212831MectaLIF Extension2Cleared 510(K)
- K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF2Cleared 510(K)
- K212520ProLift Micro Expandable Spacer System2Cleared 510(K)
- K211740DualX2Cleared 510(K)
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System2Cleared 510(K)
- K211689KEYSTONE PEEK Cage System2Cleared 510(K)
- K211474Kleiner KG2 System2Cleared 510(K)
- K212540Explorer TO System2Cleared 510(K)
- K203014EndoLIF Delta-Cage and DoubleWedge-Cage2Cleared 510(K)
- K212070KMTI S141 Lumbar Interbody Fusion System2Cleared 510(K)
- K210090Impulse AM Interbody Fusion System2Cleared 510(K)
- K211413BEE PLIF Cage2Cleared 510(K)
- K210800IO Expandable Lumbar Interbody Fusion System2Cleared 510(K)
- K211873PSX Interbody System2Cleared 510(K)
- K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device2Cleared 510(K)
- K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System2Cleared 510(K)
- K203003Pantheon IBFD2Cleared 510(K)
- K210542aprevo Transforaminal IBF2Cleared 510(K)
- K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System2Cleared 510(K)
- K211306LABYRINTH2Cleared 510(K)
- K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers2Cleared 510(K)
- K203802X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K210583SeaSpine WaveForm™ A Interbody System2Cleared 510(K)
- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System2Cleared 510(K)
- K210425Catalyft PL Expandable Interbody System2Cleared 510(K)
- K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System2Cleared 510(K)
- K210439NuVasive MOD-EX XLIF Interbody System2Cleared 510(K)
- K210728CONDUIT Instruments2Cleared 510(K)
- K210061ProLift Lateral HELO Fixated2Cleared 510(K)
- K201024Expandable Titanium PLIF/TLIF System2Cleared 510(K)
- K200919Idys ALIF 3DTi2Cleared 510(K)
- K203254Lucent 3D Spinal System2Cleared 510(K)
- K203038Toro-L Interbody Fusion System2Cleared 510(K)
- K203361ProLift Wedge Expandable Spacer System2Cleared 510(K)
- K210359Hexanium TLIF2Cleared 510(K)
- K203576FORZA Ti Spacer System2Cleared 510(K)
- K210155Duo Expandable Interbody Fusion System2Cleared 510(K)
- K202380Born PT-LIF Cage HA2Cleared 510(K)
- K200551MectaLIF Transforaminal TiPEEK2Cleared 510(K)
- K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers2Cleared 510(K)
- K203531XYPAN Expandable Lumbar Cage System2Cleared 510(K)
- K203327VERTACONNECT TLIF Cage2Cleared 510(K)
- K203683CarboClear Lumbar Cage System2Cleared 510(K)
- K203308Ali Interbody Fusion System2Cleared 510(K)
- K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System2Cleared 510(K)
- K202495SIRION Lateral Lumbar Interbody Fusion2Cleared 510(K)
- K202820Australis Anterior Lumbar Cage System2Cleared 510(K)
- K202298Lucent XP, Lucent XP Curved2Cleared 510(K)
- K201287Impulse Interbody Fusion System2Cleared 510(K)
- K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System2Cleared 510(K)
- K202034aprevo Intervertebral Body Fusion Device2Cleared 510(K)
- K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System2Cleared 510(K)
- K202587ATEC Lateral Interbody System2Cleared 510(K)
- K202198FlareHawk Interbody Fusion System2Cleared 510(K)
- K200316UNiD IB3D ALIF2Cleared 510(K)
- K201692NuVasive Modulus XLIF Interbody System2Cleared 510(K)
- K200084Zavation IBF System2Cleared 510(K)
- K202305Zavation IBF System2Cleared 510(K)
- K201939GAIA Lumbar Interbody Fusion Device (LIFD) Family2Cleared 510(K)
- K201453Fortilink Cages with TiPlus Technology2Cleared 510(K)
- K200953NuVasive® Cohere® Thoracolumbar Interbody System2Cleared 510(K)
- K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System2Cleared 510(K)
- K201367FlareHawk TiHawk9 Interbody Fusion System2Cleared 510(K)
- K201145X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K201721TruLift Expandable Spacer System2Cleared 510(K)
- K200958MODULIF-A Anterior Lumbar Interbody Fusion System2Cleared 510(K)
- K201267Adaptix Interbody System with Titan nanoLOCK Surface Technology2Cleared 510(K)
- K192863MONDRIAN Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer2Cleared 510(K)
- K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF System2Cleared 510(K)
- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage2Cleared 510(K)
- K193172Luna XD Ti Interbody Fusion System2Cleared 510(K)
- K193106SpineFrontier Lumbar Interbody Fusion Device System2Cleared 510(K)
- K200283Medussa-PL Cage2Cleared 510(K)
- K200879SeaSpine Meridian System, SeaSpine Regatta Lateral System2Cleared 510(K)
- K200920Idys ALIF ZP 3DTi2Cleared 510(K)
- K200969NEXXT MATRIXX System2Cleared 510(K)
- K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF2Cleared 510(K)
- K200991EVOL Spinal Interbody System2Cleared 510(K)
- K193457AUDERE Lumbar Spacer System2Cleared 510(K)
- K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices2Cleared 510(K)
- K193636SeaSpine Reef TH System2Cleared 510(K)
- K200613Tritanium® X TL Expandable Curved Posterior Lumbar Cage2Cleared 510(K)
- K191353COMET Lumbar Interbody Fusion Cage2Cleared 510(K)
- K200552EVOS Lumbar Interbody System2Cleared 510(K)
- K192006SIRION Lateral Lumbar Interbody System2Cleared 510(K)
- K193541NuVasive Cohere Thoracolumbar Interbody System2Cleared 510(K)
- K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System2Cleared 510(K)
- K193418SeaSpine Skipjack System2Cleared 510(K)
- K200048MectaLIF Anterior Simple2Cleared 510(K)
- K193378CarboClear Lumbar Cage System2Cleared 510(K)
- K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage2Cleared 510(K)
- K193255Largo PEEK Interbody System2Cleared 510(K)
- K193203MOJAVE Expandable Interbody System2Cleared 510(K)
- K193521Steerable Plateau Ti2Cleared 510(K)
- K193258ProLift Expandable System2Cleared 510(K)
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus2Cleared 510(K)
- K193370Nexxt Matrixx System2Cleared 510(K)
- K192115SABLE Expandable Spacer2Cleared 510(K)
- K193645nva, nvp, and nvt2Cleared 510(K)
- K192687TrellOss™-L MPF2Cleared 510(K)
- K192497EVOL ha - D Lateral Interbody Fusion System2Cleared 510(K)
- K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology2Cleared 510(K)
- K193174Keos Lumbar IBFD2Cleared 510(K)
- K181548Pantheon Spinal Pontus Interbody Fusion Device2Cleared 510(K)
- K191796Neo Cage System2Cleared 510(K)
- K182987Genesys Spine 3DP Lumbar Interbody System2Cleared 510(K)
- K192132SeaSpine Beachside System2Cleared 510(K)
- K192026Peridot Intervertebral body fusion System2Cleared 510(K)
- K192248Cortina™ [MAX] Lumbar Cage System2Cleared 510(K)
- K190721LongBow Ti2Cleared 510(K)
- K190544XIHPOS™ ZFUZE™ Interbody Fusion System2Cleared 510(K)
- K191134IB3D ALIF2Cleared 510(K)
- K1803473d Cage2Cleared 510(K)
- K192760NuVasive Modulus XLIF Interbody System2Cleared 510(K)
- K192434DualX Lumbar Intervertebral Body Fusion Device2Cleared 510(K)
- K191791TranS1 Interbody Fusion System2Cleared 510(K)
- K190483SPIRA Open Matrix ALIF and LLIF2Cleared 510(K)
- K191391HEDRON Lumbar Spacers2Cleared 510(K)
- K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage2Cleared 510(K)
- K190708AccelFix Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K191516Ali Interbody Fusion System2Cleared 510(K)
- K190398Republic Spine Restore Intervertebral Body Fusion System2Cleared 510(K)
- K183407Triton Cage2Cleared 510(K)
- K191339Zavation eZspand Interbody System2Cleared 510(K)
- K191311ATEC Lateral Interbody System2Cleared 510(K)
- K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage2Cleared 510(K)
- K190488ProLift Expandable System2Cleared 510(K)
- K190680FAVO S-TLIF2Cleared 510(K)
- K182158UNiD Patient-matched PLIF cage2Cleared 510(K)
- K191408Nexxt Matrixx System2Cleared 510(K)
- K183243Velofix TLIF Cage2Cleared 510(K)
- K191367Harrier-SA Lumbar Interbody System2Cleared 510(K)
- K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System2Cleared 510(K)
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology2Cleared 510(K)
- K183064TxTi IBF System2Cleared 510(K)
- K190684LxHA PEEK Lateral IBF System2Cleared 510(K)
- K191005ProLift® Expandable System2Cleared 510(K)
- K183560Luna 3D GEN2 Interbody Fusion System2Cleared 510(K)
- K190092UNiD Patient specific 3D printed TLIF cage2Cleared 510(K)
- K190165Capstone Control™ Spinal System2Cleared 510(K)
- K182877HALF DOME Posterior Lumbar Interbody System2Cleared 510(K)
- K190364CancelleX Porous Titanium Lumbar Interbody Device2Cleared 510(K)
- K183184FlareHawk Interbody Fusion System2Cleared 510(K)
- K182349CONCORDE LIFT2Cleared 510(K)
- K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)2Cleared 510(K)
- K183092Kuros TLIF Cage2Cleared 510(K)
- K190055Duo Lumbar Interbody Fusion Device2Cleared 510(K)
- K173518Spectrum Spine Expandable Cages (SSEC)2Cleared 510(K)
- K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices2Cleared 510(K)
- K183705IdentiTi Porous Ti Interbody System2Cleared 510(K)
- K183259Idys™ TLIF TiVac2Cleared 510(K)
- K182406Altus Spine Interbody Fusion System2Cleared 510(K)
- K183049Reliance Lumbar IBF System2Cleared 510(K)
- K183659Omnia Medical Rotary PLIF System2Cleared 510(K)
- K183447EIT Cellular Titanium Lumbar Cage - T/PLIF2Cleared 510(K)
- K181048Neo Cage System TM2Cleared 510(K)
- K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System2Cleared 510(K)
- K180230NEST Interbody System2Cleared 510(K)
- K180228II-Type Intervertebral Spacer2Cleared 510(K)
- K182210TiWAVE-L Porous Titanium Lumbar Cage2Cleared 510(K)
- K182114FlareHawk Interbody Fusion System2Cleared 510(K)
- K181589Curiteva Lumbar Interbody Fusion System2Cleared 510(K)
- K183239CoreLink F3D™ Lateral System2Cleared 510(K)
- K181899ROCCIA® PLIF2Cleared 510(K)
- K181625Life Spine Resolute™ Threaded Cage System2Cleared 510(K)
- K182584Lucent® XP2Cleared 510(K)
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® Spacers2Cleared 510(K)
- K181231DePuy Synthes T-PAL Spacer System2Cleared 510(K)
- K181970MectaLIF Posterior Extension2Cleared 510(K)
- K182746ATEC ALIF and LLIF Spacer System2Cleared 510(K)
- K182470Plateau Spacer System2Cleared 510(K)
- K181963ostaPek Interbody Fusion Cages2Cleared 510(K)
- K181829Velofix TLIF Cage2Cleared 510(K)
- K181837Spinal Elements Ti-Bond coated devices2Cleared 510(K)
- K182322Duo Lumbar Interbody Fusion Device2Cleared 510(K)
- K181644EIT Cellular Titanium® Lumbar Cage LLIF2Cleared 510(K)
- K181860NuVasive Cohere Thoracolumbar Interbody System2Cleared 510(K)
- K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices2Cleared 510(K)
- K181397DualX2Cleared 510(K)
- K181591Fixated Asfora BULLET CAGE® (FABC)2Cleared 510(K)
- K181702Tranquil-L Interbody System2Cleared 510(K)
- K181337Sypher Spacer System2Cleared 510(K)
- K181655Renovis S180 Lateral Lumbar Interbody Fusion System2Cleared 510(K)
- K181380LnK Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K181483Tranquil Interbody System2Cleared 510(K)
- K180373CancelleX Porous Titanium Lumbar Interbody Device2Cleared 510(K)
- K181347Aries® Lumbar Interbodies2Cleared 510(K)
- K181792Duo™ Lumbar Interbody Fusion Device2Cleared 510(K)
- K180990TirboLOX-L Lumbar IBFD2Cleared 510(K)
- K180777K2M Expandable Interbody System2Cleared 510(K)
- K180556Corelink Foundation 3D Anterior Lumbar System2Cleared 510(K)
- K180076Ti 3Z Interbody System2Cleared 510(K)
- K181453ATEC ALIF Spacer System2Cleared 510(K)
- K173947Lumbar Interbody Fusion System (OLLIF)2Cleared 510(K)
- K181079SeaSpine Regatta Lateral System2Cleared 510(K)
- K181014Tritanium PL Cage2Cleared 510(K)
- K181030Rubicon Lumbar Interbody Fusion System2Cleared 510(K)
- K180963ROCCIA ALIF, ROCCIA TLIF2Cleared 510(K)
- K181246Zavation IBF System2Cleared 510(K)
- K173864Peekplus® Interbody Fusion Device2Cleared 510(K)
- K181203Juliet Ti2Cleared 510(K)
- K180724SPIRA Open Matrix LLIF2Cleared 510(K)
- K173189Lumfuse TP2Cleared 510(K)
- K180687Reliance Lumber IBF System2Cleared 510(K)
- K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX2Cleared 510(K)
- K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System2Cleared 510(K)
- K180437Hexanium® TLIF2Cleared 510(K)
- K173892NuVasive® XLX Interbody System2Cleared 510(K)
- K180071STYLO Interbody Fusion Device2Cleared 510(K)
- K171151ACRON™ TLIF System2Cleared 510(K)
- K173782UNiD Patient Specific 3D printed cage2Cleared 510(K)
- K172947HALF DOME Posterior Lumbar Interbody System2Cleared 510(K)
- K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System2Cleared 510(K)
- K180431Cortina [MAX] Lumbar Cage System2Cleared 510(K)
- K171495Zyston Strut Open Titanium Spacer System2Cleared 510(K)
- K173537CONCORDE LIFT™2Cleared 510(K)
- K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System2Cleared 510(K)
- K172105The Plateau-LO Spacer System2Cleared 510(K)
- K172828Double Medical Cage System2Cleared 510(K)
- K172816TiGer Shark™ System2Cleared 510(K)
- K171312FortiCore®2Cleared 510(K)
- K173283Reliance Lumbar IBF System2Cleared 510(K)
- K172696FORZA® XP Expandable Spacer System2Cleared 510(K)
- K173476Tritanium® TL Curved Posterior Lumbar Cage2Cleared 510(K)
- K173702Juliet Ti LL2Cleared 510(K)
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers2Cleared 510(K)
- K171434ROCCIA® MultiLIF2Cleared 510(K)
- K173182ProLift® Expandable System2Cleared 510(K)
- K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages2Cleared 510(K)
- K172465Idys™ TLIF 3DTi Cages2Cleared 510(K)
- K172349InFill® Interbody Fusion Device2Cleared 510(K)
- K172009Cascadia Interbody System2Cleared 510(K)
- K170389TAURUS PEEK Cage System2Cleared 510(K)
- K172756Varian cage2Cleared 510(K)
- K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System2Cleared 510(K)
- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System2Cleared 510(K)
- K172419Velofix™ TLIF Cage2Cleared 510(K)
- K170553Altus Spine Interbody Fusion System2Cleared 510(K)
- K172020Arlington PLIF/TLIF Cage2Cleared 510(K)
- K170235Lucent®2Cleared 510(K)
- K163595IMPIX 3D Print Cages2Cleared 510(K)
- K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device2Cleared 510(K)
- K170341Medussa-PL Cage2Cleared 510(K)
- K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)2Cleared 510(K)
- K173022SeaSpine Ventura NanoMetalene System2Cleared 510(K)
- K172341NuVasive® Modulus TLIF Interbody System2Cleared 510(K)
- K172334Ortus™ Expandable Lumbar Interbody Fusion System2Cleared 510(K)
- K171914Cortina™ Lumbar Cage System2Cleared 510(K)
- K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology2Cleared 510(K)
- K172123NuVasive® Modulus XLIF Interbody System2Cleared 510(K)
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology2Cleared 510(K)
- K170119Calix Lumbar Spinal Implant System2Cleared 510(K)
- K171633NuVasive TLX Interbody System2Cleared 510(K)
- K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System2Cleared 510(K)
- K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium2Cleared 510(K)
- K172064Ti-Diagon Oblique TLIF2Cleared 510(K)
- K171519FLXfit™2Cleared 510(K)
- K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)2Cleared 510(K)
- K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device2Cleared 510(K)
- K171329Altus Spine Titanium Interbody Fusion System2Cleared 510(K)
- K171660Duo Lumbar Interbody Fusion Device2Cleared 510(K)
- K171657ShurFit 2C Lumbar Interbody Fusion System2Cleared 510(K)
- K170888Renovis S141 Lumbar Interbody Fusion System2Cleared 510(K)
- K170851Anterior Spine Truss System (STS) Interbody Fusion Device2Cleared 510(K)
- K170919The TiBow Expandable Spacer System2Cleared 510(K)
- K171630LumFuse-TP2Cleared 510(K)
- K171724Rampart L Lumbar Interbody Fusion Device2Cleared 510(K)
- K171425CONCORDE LIFT2Cleared 510(K)
- K171656Genesys Spine Apache Interbody Fusion System2Cleared 510(K)
- K170676HD Lumbar Interbody System2Cleared 510(K)
- K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages2Cleared 510(K)
- K171031CRESCENT™ Spinal System2Cleared 510(K)
- K170399Endoskeleton TO Interbody Fusion Device (IBD)2Cleared 510(K)
- K161710SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL2Cleared 510(K)
- K170297Tranquil Interbody System2Cleared 510(K)
- K170962NuVasive® CoRoent® Thoracolumbar System2Cleared 510(K)
- K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System2Cleared 510(K)
- K171468FUSE Spinal System2Cleared 510(K)
- K162986SPIRA Open Matrix ALIF2Cleared 510(K)
- K170890TELIX K Interbody System2Cleared 510(K)
- K170395Talos® Lumbar (HA) PEEK IBF Devices2Cleared 510(K)
- K162212DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM2Cleared 510(K)
- K171097MOJAVE Expandable Interbody System2Cleared 510(K)
- K163481HALF DOME Posterior Lumbar Interbody System2Cleared 510(K)
- K163707NuVasive CoRoent Ti-C System2Cleared 510(K)
- K170572Summit Spine Yellowstone Lumbar Interbody Fusion System2Cleared 510(K)
- K170511NeoFuse HA Enhanced PLIF/TLIF2Cleared 510(K)
- K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System2Cleared 510(K)
- K163386Keos Lumbar IBFD2Cleared 510(K)
- K163246Leva Anterior Expandable Spacer System2Cleared 510(K)
- K162206Zavation IBF2Cleared 510(K)
- K170243LOSPA IS TLIF & DLIF Cages2Cleared 510(K)
- K162693VertebraLINK Fusion Platform2Cleared 510(K)
- K163230NuVasive Modulus XLIF Interbody System2Cleared 510(K)
- K163364MOJAVE Expandable Interbody System2Cleared 510(K)
- K170512Altus Spine Titanium Interbody Fusion System2Cleared 510(K)
- K163409Rampart(TM) T Lumbar Interbody Fusion Device2Cleared 510(K)
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer2Cleared 510(K)
- K162918Atlas Spine Expandable Interbody System2Cleared 510(K)
- K162879Elite Expandable Interbody Fusion Device2Cleared 510(K)
- K160976Altus Spine Interbody Fusion System2Cleared 510(K)
- K163180Hubble II2Cleared 510(K)
- K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System2Cleared 510(K)
- K162327COUGAR® LS Lateral Cage System and COUGAR® System2Cleared 510(K)
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)2Cleared 510(K)
- K162431Luna 3D Interbody Fusion System2Cleared 510(K)
- K160959Xsert Lumbar Expandable Interbody System2Cleared 510(K)
- K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)2Cleared 510(K)
- K162262Tritanium® PL Cage2Cleared 510(K)
- K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System2Cleared 510(K)
- K160924Amendia Interbody Fusion Devices2Cleared 510(K)
- K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System2Cleared 510(K)
- K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene2Cleared 510(K)
- K160074Rampart D Lumbar Interbody Fusion Device2Cleared 510(K)
- K160076XCage™ Interbody Fusion System2Cleared 510(K)
- K162426nva, nvp, and nvt2Cleared 510(K)
- K162264Cascadia Interbody System2Cleared 510(K)
- K153665PROW FUSION-L2Cleared 510(K)
- K161888JULIET® LL Lateral Lumbar Cage2Cleared 510(K)
- K161485Nanovis Intervertebral Body Fusion System and Forticore(R)2Cleared 510(K)
- K161230NuVasive Lumbar Interbody Implants2Cleared 510(K)
- K160646XYcor® Expandable Spinal Spacer System2Cleared 510(K)
- K161405Valeo II Interbody Fusion Device System2Cleared 510(K)
- K160856SpineView X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K160699VIRTU Lumbar Spacer System2Cleared 510(K)
- K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System2Cleared 510(K)
- K160955Tritanium® PL Cage2Cleared 510(K)
- K160631Keos Lumbar IBFD2Cleared 510(K)
- K153621Juliet® Ti2Cleared 510(K)
- K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device2Cleared 510(K)
- K153786PROW FUSION-V2Cleared 510(K)
- K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System2Cleared 510(K)
- K160715AccuLIF TL and PL Cage2Cleared 510(K)
- K152501Spinal Jaxx Interbody Fusion Device2Cleared 510(K)
- K160916CoRoent® Ti-C System2Cleared 510(K)
- K160874Nanovis Intervertebral Body Fusion System and FortiCore®2Cleared 510(K)
- K152011Lucent Intervertebral Body Fusion Device2Cleared 510(K)
- K153436LATERAL Spine Truss System2Cleared 510(K)
- K160463Reliance Lumbar IBF System2Cleared 510(K)
- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System2Cleared 510(K)
- K153615NeoFuse HA Enhanced PLIF/TLIF2Cleared 510(K)
- K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF2Cleared 510(K)
- K153123Genesys Spine Apache Interbody Fusion System2Cleared 510(K)
- K153222Leva Spacer System2Cleared 510(K)
- K153419NuVasive CoRoent Thoracolumbar System2Cleared 510(K)
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer2Cleared 510(K)
- K160464Opticage(R) Expandable Interbody Fusion Device2Cleared 510(K)
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System2Cleared 510(K)
- K152200SurgTech Interbody System2Cleared 510(K)
- K160547Cascadia Interbody System2Cleared 510(K)
- K153782NuVasive® Lumbar Interbody Implants2Cleared 510(K)
- K153627NuVasive® TLX Interbody System2Cleared 510(K)
- K151665SUSTAIN Additional Implants2Cleared 510(K)
- K160418PERIMETER Interbody Fusion Device2Cleared 510(K)
- K153400ProLift Expandable System2Cleared 510(K)
- K151406Cogent Lateral Interbody System2Cleared 510(K)
- K152539SpineView X-Pac Expandable Lumbar Cage System2Cleared 510(K)
- K153082Rampart A Lumbar Interbody Fusion Device2Cleared 510(K)
- K152512Half Dome Posterior Lumbar Interbody System2Cleared 510(K)
- K153695Biomet Spine Fusion System2Cleared 510(K)
- K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer2Cleared 510(K)
- K152620Spine Wave Gen II Expandable Interbody System2Cleared 510(K)
- K153356Spine Innovation Interbody System2Cleared 510(K)
- K152475FORZA PTC Spacer System2Cleared 510(K)
- K151310Amendia Interbody Fusion Devices2Cleared 510(K)
- K152651AccuLIF TL and PL Cage2Cleared 510(K)
- K151900VariLift-L Interbody Fusion Device2Cleared 510(K)
- K152355Twin Peaks Lumbar Interbody Fusion System2Cleared 510(K)
- K151773CONCORDE Bullet Lumbar Interbody System2Cleared 510(K)
- K152304Tritanium PL Cage2Cleared 510(K)
- K152259InFill Interbody Fusion Device2Cleared 510(K)
- K152277PIVOX(tm) Oblique Lateral Spinal System2Cleared 510(K)
- K151819Integrity Spine Lumbar Interbody Fusion System2Cleared 510(K)
- K152156Opticage Expandable Interbody Fusion Device2Cleared 510(K)
- K151785Px HA PEEK IBF System2Cleared 510(K)
- K151352CONCORDE Bullet Spinal System2Cleared 510(K)
- K151408LOSPA IS Spinal System2Cleared 510(K)
- K143518Valeo Spacer System and Valeo II Interbody Fusion Device System2Cleared 510(K)
- K143479Bluefin Interbody System2Cleared 510(K)
- K151472NuVasive CoRoent Lumbar System2Cleared 510(K)
- K151322Amendia Interbody Fusion Devices2Cleared 510(K)
- K151756STERISPINE LC CAGE2Cleared 510(K)
- K150481Cascadia Interbody System2Cleared 510(K)
- K151140LnK Lumbar Interbody Fusion Cage System2Cleared 510(K)
- K151056Aesculap T-Space PEEK and XP Spinal System2Cleared 510(K)
- K150395Omega LIF System2Cleared 510(K)
- K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System2Cleared 510(K)
- K151128CAPSTONE Spinal System, CLYDESDALE Spinal System2Cleared 510(K)
- K151483Biomet Spine Fusion System2Cleared 510(K)
- K151020Rampart-T Interbody Fusion System2Cleared 510(K)
- K143143PATHWAY ELIF2Cleared 510(K)
- K151654PROW FUSION2Cleared 510(K)
- K151184InFill Interbody Fusion Devices2Cleared 510(K)
- K150321EVOS Lumbar Interbody System2Cleared 510(K)
- K151581Leva Spacer System2Cleared 510(K)
- K151143EndoLIF On-Cage2Cleared 510(K)
- K150500Px PEEK IBF System2Cleared 510(K)
- K151276DePuy Synthes T-PAL Ti Spacer2Cleared 510(K)
- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion System2Cleared 510(K)
- K142559ELEVATE Spinal System2Cleared 510(K)
- K143740Battalion Universal Spacer System2Cleared 510(K)
- K150061Lucent; Lucent Ti-Bond Systems2Cleared 510(K)
- K142504SpineFrontier Lumbar Interbody Fusion Device System2Cleared 510(K)
- K150152The Octane Straight Intervertebral Fusion Device, Ti Coated2Cleared 510(K)
- K150954Elite L Expandable Lumbar Fusion System2Cleared 510(K)
- K143595NuVasive(R) CCX-L Interbody System2Cleared 510(K)
- K142392Zavation Posterior LEIF2Cleared 510(K)
- K140348INTERBODY CAGE2Cleared 510(K)
- K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)2Cleared 510(K)
- K150206InFill Interbody Fusion Devices2Cleared 510(K)
- K143158Xenco Medical Lumbar Interbody System2Cleared 510(K)
- K141665NuVasive CoRoent System2Cleared 510(K)
- K142634Biomet Spine Fusion System2Cleared 510(K)
- K150285Leva(TM) Spacer System2Cleared 510(K)
- K143616AccuLIF TL and PL Cage2Cleared 510(K)
- K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)2Cleared 510(K)
- K143126Renovis S141 Lumbar Interbody Cage System2Cleared 510(K)
- K141980LEVA (TM) SPACER SYSTEM2Cleared 510(K)
- K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene2Cleared 510(K)
- K141135JULIET LL2Cleared 510(K)
- K142594nva, nvp, nvt2Cleared 510(K)
- K140716OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE2Cleared 510(K)
- K142023LUNA INTERBODY SYSTEM2Cleared 510(K)
- K141896COROENT SYSTEM2Cleared 510(K)
- K142347Amedica Valeo II Interbody Fusion Device2Cleared 510(K)
- K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL2Cleared 510(K)
- K142101ABACUS (TM) SPACER SYSTEM2Cleared 510(K)
- K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL2Cleared 510(K)
- K142193COGENT MED-LIF XL2Cleared 510(K)
- K142277JULIET PO2Cleared 510(K)
- K140319COROENT TI-C SYSTEM2Cleared 510(K)
- K140577INNESIS PEEK TL CAGE2Cleared 510(K)
- K133577CLYDESDALE(R) SPINAL SYSTEM2Cleared 510(K)
- K1421124WEB SPINAL IMPLANT PRODUCTS2Cleared 510(K)
- K133717LONGBOW SPACER SYSTEM2Cleared 510(K)
- K141405MOBIS II ST SPINAL IMPLANT2Cleared 510(K)
- K141443INFRONT LUMBAR INTERBODY FUSION SYSTEM2Cleared 510(K)
- K140770MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM2Cleared 510(K)
- K132907PLIF LITE AND TLIF LITE2Cleared 510(K)
- K141217ACCULIF TL AND PL CAGE2Cleared 510(K)
- K140142CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)2Cleared 510(K)
- K133813FLXFIT INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K133053MILESTONE SPINAL SYSTEM2Cleared 510(K)
- K140162AP EXPANDABLE XLIF SYSTEM2Cleared 510(K)
- K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICE2Cleared 510(K)
- K140411ALTERA SPACER2Cleared 510(K)
- K140659COROENT THORACOLUMBAR IMPLANTS2Cleared 510(K)
- K140759BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL2Cleared 510(K)
- K140564BN LUMBAR CAGE SYSTEM2Cleared 510(K)
- K132852PEEK CAGE FOR THE VERTEBRAL SPINE2Cleared 510(K)
- K140709SKYHAWK INTERBODY FUSION SYSTEM2Cleared 510(K)
- K133514XCAGE INTERBODY FUSION SYSTEM2Cleared 510(K)
- K133418INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM2Cleared 510(K)
- K123607OCTANE ELEVATE SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K140303ALAMO T2Cleared 510(K)
- K140474JULIET OL2Cleared 510(K)
- K131612ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES2Cleared 510(K)
- K132738COGENT MED-LIF2Cleared 510(K)
- K133340SPINEWORKS ANTERIOR LUMBAR DEVICE2Cleared 510(K)
- K140007ABACUS TM SPACER SYSTEM2Cleared 510(K)
- K133614ALEUTIAN IBF SYSTEM2Cleared 510(K)
- K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 602Cleared 510(K)
- K133455CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC2Cleared 510(K)
- K134038CAMBER SPINE DIAGON OBLIQUE CAGE2Cleared 510(K)
- K133893STERISPINE LC CAGE2Cleared 510(K)
- K133205CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM2Cleared 510(K)
- K133459ELITE IBF2Cleared 510(K)
- K133583OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 90702Cleared 510(K)
- K133557JULIET LL LATERAL LUMBAR CAGE2Cleared 510(K)
- K131292DEROYAL SPINE SPACER SYSTEM2Cleared 510(K)
- K133967INTERBODY CAGE SYSTEM2Cleared 510(K)
- K133184ARDIS INTERBODY SYSTEM2Cleared 510(K)
- K133192MECTALIF TIPEEK2Cleared 510(K)
- K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K133371RAMPART-L2Cleared 510(K)
- K133645PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM2Cleared 510(K)
- K132601COROENT STERILE IMPLANTS SYSTEM2Cleared 510(K)
- K133650CAPSTONE SPINAL SYSTEM2Cleared 510(K)
- K132790INFIX ANTERIOR LUMBAR SYSTEM2Cleared 510(K)
- K130913GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM2Cleared 510(K)
- K132897CLYDESDALE SPINAL SYSTEM2Cleared 510(K)
- K133126K7 LUMBAR SPACERS2Cleared 510(K)
- K133216CRESCENT SPINAL SYSTEM2Cleared 510(K)
- K131669PERIMETER INTERBODY FUSION DEVICE2Cleared 510(K)
- K130274BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM2Cleared 510(K)
- K131350CALIX LUMBAR SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K130254PROW FUSION2Cleared 510(K)
- K131178IDYS LIF CAGES2Cleared 510(K)
- K131981CEZANNE II INTERBODY FUSION SYSTEM2Cleared 510(K)
- K132719STAXX IBL SYSTEM2Cleared 510(K)
- K132700PERIMETER INTERBODY FUSION DEVICE2Cleared 510(K)
- K132479OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-002Cleared 510(K)
- K132053RAMPART-O, RAMPART-T2Cleared 510(K)
- K132505ACCULIF TL AND PL CAGE2Cleared 510(K)
- K131540INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K131296VARILIFT-L INTERBODY FUSION DEVICE2Cleared 510(K)
- K131242ARDIS INTERBODY SYSTEM2Cleared 510(K)
- K131082INTERFORM INTERBODY CAGE SYSTEM2Cleared 510(K)
- K131071STAXX IBL SYSTEM2Cleared 510(K)
- K130820EXPANDABLE LUMBAR INTERBODY SYSTEM2Cleared 510(K)
- K130478SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS2Cleared 510(K)
- K123027CAPSTONE(R) SPINAL SYSTEM2Cleared 510(K)
- K131077LIFE SPINE PLATEAU SPACER SYSTEM2Cleared 510(K)
- K131671MECTALIF2Cleared 510(K)
- K131372MOBIS II2Cleared 510(K)
- K122957TEZO TITANIUM CAGE FAMILY2Cleared 510(K)
- K131443COALIGN INNOVATIONS ACCULIF XL IBF CAGE2Cleared 510(K)
- K130630PLATEAU SPACER SYSTEM TITANIUM2Cleared 510(K)
- K124012INFILL OBLIQUE TLIF DEVICE2Cleared 510(K)
- K131216RAMPART O2Cleared 510(K)
- K130699ALEUTIAN SPINAL SYSTEM2Cleared 510(K)
- K122639SYNTHES SYNCAGE EVOLUTION SPACER2Cleared 510(K)
- K130506IMSE P-TLIF2Cleared 510(K)
- K123913LATIS SPACER2Cleared 510(K)
- K130434OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC2Cleared 510(K)
- K113781PANTHEON SPINAL IBFD SYSTEM2Cleared 510(K)
- K130548EPICAGE INTERBODY FUSION DEVICE2Cleared 510(K)
- K123461STAXX(R) IB SYSTEM2Cleared 510(K)
- K123978CAPSTONE L SPINAL SYSTEM2Cleared 510(K)
- K130194ACCULIF XL CAGE2Cleared 510(K)
- K123997TRANS1LATERAL INTERBODY FUSION SYSTEM2Cleared 510(K)
- K123100INTESS LUMBAR CAGE2Cleared 510(K)
- K130396RAMPART O AND RAMPART P2Cleared 510(K)
- K123652SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE2Cleared 510(K)
- K122037ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST2Cleared 510(K)
- K123602TM ARDIS INTERBODY SYSTEM INSERTER2Cleared 510(K)
- K122967LUCENT2Cleared 510(K)
- K123969XIPHOS2Cleared 510(K)
- K123281ACCULIF TL-PEEK CAGE2Cleared 510(K)
- K123231CALIBER SPACERS2Cleared 510(K)
- K120464INNESIS PEEK CAGE2Cleared 510(K)
- K123752ACCULIF TL AND PL CAGE2Cleared 510(K)
- K121254CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE2Cleared 510(K)
- K123180FALCON SPACER2Cleared 510(K)
- K121693A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)2Cleared 510(K)
- K122097PATRIOT SPACERS2Cleared 510(K)
- K123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM2Cleared 510(K)
- K122956FUSELOX LUMBAR INTERBODY FUSION DEVICE2Cleared 510(K)
- K122989BIOMET LATERAL SPACER SYSTEM2Cleared 510(K)
- K122896COUGAR LS 15 LATERAL CAGE SYSTEM2Cleared 510(K)
- K121581BOX PEEK VBR SYSTEM,2Cleared 510(K)
- K120401ALAMO T2Cleared 510(K)
- K121567ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM2Cleared 510(K)
- K122021STERISPINE LC CAGE2Cleared 510(K)
- K122591CLYDESDALE SPINAL SYSTEM2Cleared 510(K)
- K122047ALAMO P2Cleared 510(K)
- K122317TETRIS II2Cleared 510(K)
- K121760CAPSTONE SPINAL SYSTEM2Cleared 510(K)
- K121892PHANTOM PLUS CERAMIC CAGE SYSTEM2Cleared 510(K)
- K120991TRANS1 INTERBODY FUSION SYSTEM2Cleared 510(K)
- K121733INFILL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K121096VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM2Cleared 510(K)
- K121683ACCULIF TL CAGE2Cleared 510(K)
- K120966DEPUY PULSE LUMBAR CAGE SYSTEM2Cleared 510(K)
- K121332LOOP CAGE2Cleared 510(K)
- K121333WAVE D CAGE2Cleared 510(K)
- K121330WAVE O CAGE2Cleared 510(K)
- K121288FUSE CAGE2Cleared 510(K)
- K120918NUVASIVE COROENT TITANIUM SYSTEM2Cleared 510(K)
- K121246MEDYSSY LT CAGE SYSTEM2Cleared 510(K)
- K120203TM-400 DEVICE2Cleared 510(K)
- K121129SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE2Cleared 510(K)
- K113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION2Cleared 510(K)
- K110632LUCENT OR LUCENT MAGNUM2Cleared 510(K)
- K121116PLATEAU SPACER SYSTEM2Cleared 510(K)
- K112986LATERAL FUSION DEVICE2Cleared 510(K)
- K120063VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM2Cleared 510(K)
- K112696TWIN PEAKS LUMBAR CAGE2Cleared 510(K)
- K120368CAPSTONE CONTROL SPINAL SYSTEM2Cleared 510(K)
- K120576ZAVATION IBF SYSTEM2Cleared 510(K)
- K112648ASFORA BULLET CAGE2Cleared 510(K)
- K113540RELIANCE LUMBAR IBF SYSTEM2Cleared 510(K)
- K113478PLIF CAGE2Cleared 510(K)
- K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI2Cleared 510(K)
- K120293SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE2Cleared 510(K)
- K120024MECTALIF TRANSFORAMINAL2Cleared 510(K)
- K113642PERIMETER INTERBODY FUSION DEVICE2Cleared 510(K)
- K111726PATHWAY AVID2Cleared 510(K)
- K113447RISE SPACER2Cleared 510(K)
- K113030SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE2Cleared 510(K)
- K113527OPTICAGE INTERBODY FUSION DEVICE2Cleared 510(K)
- K113138ALEUTIAN SYSTEM2Cleared 510(K)
- K113528CLYDESDALE(R) SPINAL SYSTEM2Cleared 510(K)
- K1123164-WEB ALIF SPINAL TRUSS SYSTEM (STS)2Cleared 510(K)
- K113348COUGAR SYSTEM2Cleared 510(K)
- K113465ACCULIF TL CAGE2Cleared 510(K)
- K112095ACCULIF TL-PEEK IBF CAGE2Cleared 510(K)
- K112405CLYDESDALES SPINAL SYSTEM2Cleared 510(K)
- K110562TELAMON PEEK SPINAL SYSTEM2Cleared 510(K)
- K112359PROW FUSION2Cleared 510(K)
- K111512BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM2Cleared 510(K)
- K111965VUSION(R) OS2Cleared 510(K)
- K110783VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE2Cleared 510(K)
- K112014ZYSTON STRAIGHT SPACER SYSTEM2Cleared 510(K)
- K111354GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)2Cleared 510(K)
- K110694CONCORDE BULLET SPINAL SYSTEM2Cleared 510(K)
- K112496PIONEER CROSSFUSE II IBF/VBR SYSTEM2Cleared 510(K)
- K111553SPINEFRONTIER LUMBAR IBF SYSTEM2Cleared 510(K)
- K111880SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE2Cleared 510(K)
- K110659MEDICAL CONCEPTS INTERBODY FUSION SYSTEM2Cleared 510(K)
- K111166A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)2Cleared 510(K)
- K111525PERIMETER INTERBODY FUSION DEVICE2Cleared 510(K)
- K110543CRESCENT (R) SPINAL SYSTEM TITANIUM2Cleared 510(K)
- K100305ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER2Cleared 510(K)
- K111774PATHWAY MODEL 07XXXX2Cleared 510(K)
- K103731CAPSTONE R SPINAL SYSTEM2Cleared 510(K)
- K111569PLATEAU SPACER SYSTEM2Cleared 510(K)
- K110650ZYSTON ARC INTERBODY SPACER2Cleared 510(K)
- K110843ALEUTIAN SPACER SYSTEM2Cleared 510(K)
- K110933SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE2Cleared 510(K)
- K110927MECTALIF2Cleared 510(K)
- K110226INTERFUSE T INVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K110454COUGAR LS LATERAL CAGE SYSTEM2Cleared 510(K)
- K102026SEASPINE SPACER SYSTEM2Cleared 510(K)
- K102957CUTTING EDGE SPINE INTERBODY FUSION DEVICE2Cleared 510(K)
- K110177HELENA SYSTEM2Cleared 510(K)
- K103729INFILL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K110067LP CAGE2Cleared 510(K)
- K110270ACCULIF CAGE2Cleared 510(K)
- K103666LANX LATERAL2Cleared 510(K)
- K103111FORZA SPACER SYSTEM2Cleared 510(K)
- K103814PEZO INTERBODY CAGES SYSTEM2Cleared 510(K)
- K103743CONCORDE CURVE SYSTEM2Cleared 510(K)
- K103488CONCORDE BULLET CAGE SYSTEM2Cleared 510(K)
- K100945FUSE PLIF CAFE2Cleared 510(K)
- K110045INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K103297REDONDO-L2Cleared 510(K)
- K083894ALIF SPINAL TRUSS INTERBODY FUSION DEVICE2Cleared 510(K)
- K102322STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)2Cleared 510(K)
- K103228PARAMOUNT R IBF DEVICE2Cleared 510(K)
- K102293CALIBER SPACER2Cleared 510(K)
- K103034GENESYS SPINE INTERBODY FUSION SYSTEM2Cleared 510(K)
- K102313PATRIOT TRANSCONTINENTAL M SPACERS2Cleared 510(K)
- K101923CONCORDE CURVE SYSTEM2Cleared 510(K)
- K102067ENDOSKELETON TO2Cleared 510(K)
- K102277INTERFUSE T INVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K100042DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM2Cleared 510(K)
- K101301STALIF MIDLINE2Cleared 510(K)
- K100037ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD2Cleared 510(K)
- K100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T2Cleared 510(K)
- K101051AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX2Cleared 510(K)
- K100865AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX2Cleared 510(K)
- K100743ATLAS SPINE PIVOTING SYSTEM2Cleared 510(K)
- K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM2Cleared 510(K)
- K100544IMPIX LUMBAR INTERBODY DEVICE2Cleared 510(K)
- K101720JULIET OL2Cleared 510(K)
- K101085SPINESMITH CYNCH SPINAL SYSTEM2Cleared 510(K)
- K092815S-LIF INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K100175CLYDESDALE SPINAL SYSTEM2Cleared 510(K)
- K083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF2Cleared 510(K)
- K100089SYNTHES T-PAL SPACER2Cleared 510(K)
- K092901EPICAGE INTERBODY FUSION DEVICE2Cleared 510(K)
- K094025CRESCENT SPINAL SYSTEM2Cleared 510(K)
- K093669SEC IBF CAGE2Cleared 510(K)
- K093864AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX2Cleared 510(K)
- K093015BINDER INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K092574ESL SPINAL SYSTEM2Cleared 510(K)
- K092774ATLAS INTERVERTEBRAL BODY CAGE2Cleared 510(K)
- K091278VALEO SPACER SYSTEM2Cleared 510(K)
- K0921624CIS PEEK, PLIF AND TLIF CAGE SYSTEM2Cleared 510(K)
- K093704AVS PL PEEK SPACERS2Cleared 510(K)
- K093675INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 90762Cleared 510(K)
- K093242PATRIOT TRANSCONTINENTAL LLIF SPACER2Cleared 510(K)
- K092017PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)2Cleared 510(K)
- K083626DISTRACTABLE WAVE CAGE2Cleared 510(K)
- K090353PERIMETER INTERBODY FUSION DEVICE2Cleared 510(K)
- K092193SPINAL USA INTERBODY CAGES2Cleared 510(K)
- K091122DIANA FUSION CAGE2Cleared 510(K)
- K091638DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM20312Cleared 510(K)
- K090048ASFORA BULLET CAGE SYSTEM2Cleared 510(K)
- K091381IBEX SPINAL SYSTEM2Cleared 510(K)
- K091988MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 90762Cleared 510(K)
- K090707TALOS INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K090507MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM2Cleared 510(K)
- K090566PATHWAY AVID2Cleared 510(K)
- K081917DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS2Cleared 510(K)
- K090899DEPUY SPINE LATERAL SYSTEM2Cleared 510(K)
- K090425GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM2Cleared 510(K)
- K090816STRYKER SPINE AVS PL PEEK SPACERS2Cleared 510(K)
- K090782NOVEL ALIF SPINAL SPACER SYSTEM2Cleared 510(K)
- K090166AVS ANTERIOR LARGE PEEK SPACERS2Cleared 510(K)
- K082698ALEUTIAN IBF SYSTEM2Cleared 510(K)
- K083815LANX FUSION SYSTEM2Cleared 510(K)
- K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)2Cleared 510(K)
- K090064EMINENT SPINE INTERBODY FUSION SYSTEM2Cleared 510(K)
- K090376SPINESMITH CYNCH SPINAL SYSTEM2Cleared 510(K)
- K083661AVS TL PEEK SPACERS2Cleared 510(K)
- K081888DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K082262LDR SPINE ROI INTERBODY FUSION SYSTEM2Cleared 510(K)
- K082406EXPANDABLE PEEK-OPTIMA IMPLANT2Cleared 510(K)
- K082712THEKEN SPINE VU EPOD AND VU LPOD SYSTEM2Cleared 510(K)
- K083026CLYDESDALE SPINAL SYSTEM2Cleared 510(K)
- K082128DEPUY SPINE LATERAL CAGE SYSTEM2Cleared 510(K)
- K081673DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K082310HOLLYWOOD, PACIFICA, REDONDO, VENTURA2Cleared 510(K)
- K082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K082260INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES2Cleared 510(K)
- K082732MODIFICATION TO: CAPSTONE SPINAL SYSTEM2Cleared 510(K)
- K081196SPINAL USA VBR SYSTEM2Cleared 510(K)
- K082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM2Cleared 510(K)
- K082342MODIFICATION TO CAPSTONE SPINAL SYSTEM2Cleared 510(K)
- K082235BLACKSTONE PILLAR XL PEEK SPACERS2Cleared 510(K)
- K081636PEEK-OPTIMA ALIF SPACER2Cleared 510(K)
- K081968MODIFICATION TO LUCENT2Cleared 510(K)
- K082014STRYKER SPINE AVS PL PEEK SPACERS2Cleared 510(K)
- K081177BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM2Cleared 510(K)
- K080537L-VARLOCK2Cleared 510(K)
- K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)2Cleared 510(K)
- K080673INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K080588SCIENT'X TRIBECA VBR2Cleared 510(K)
- K080411PLATEAU SPACER SYSTEM2Cleared 510(K)
- K080314SPINAL USA INTERBODY FUSION DEVICE2Cleared 510(K)
- K073177PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM2Cleared 510(K)
- K080401SHELL CAGE, WAVE CAGE, LOOP CAGE2Cleared 510(K)
- K080281PATHWAY2Cleared 510(K)
- K071983AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE2Cleared 510(K)
- K073440FOUNDATION CAGE2Cleared 510(K)
- K073291CAPSTONE SPINAL SYSTEM2Cleared 510(K)
- K080058TURBO PRIME IBD SYSTEM2Cleared 510(K)
- K080083INTREPID SPINAL SYSTEM2Cleared 510(K)
- K080758AVS PL PEEK SPACERS, MODELS 48351 AND 483532Cleared 510(K)
- K073470AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX2Cleared 510(K)
- K073669ORIA NATURA SPACER2Cleared 510(K)
- K073202ARDIS SPACER2Cleared 510(K)
- K073144LANX INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K072970PATRIOT SPACERS2Cleared 510(K)
- K073348LUCENT MAGNUM2Cleared 510(K)
- K072791ORACLE SPACER, OPAL SPACER2Cleared 510(K)
- K072226IMPIX SPACER2Cleared 510(K)
- K071795NUVASIVE COROENT SYSTEM2Cleared 510(K)
- K071724LUCENT2Cleared 510(K)
- K072289SPINEFRONTIER DORADO VBR2Cleared 510(K)
- K072120PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P970015INTER FIX TM THREADED FUSION DEVICE2PMA Approval
- P970015LT-CAGE LUMBAR TAPERED FUSION DEVICE2PMA Approval
- P970015LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)2PMA Approval
- P980048BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P970015INTER FIX THREADED FUSION DEVICE2PMA Approval
- P950002BAK VISTA INTERBODY FUSION CAGE2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P970015LT-CAGE LUMBAR TAPERED FUSION DEVICE2PMA Approval
- P970015LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE2PMA Approval
- P950019RAY TFC AND RAY TFC UNITE2PMA Approval
- P950002VISTA LORDOTIC INTERBODY FUSION CAGE2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P950002BAK VISTA INTERBODY FUSION CAGE2PMA Approval
- P950019RAY TFC UNITE2PMA Approval
- P970015INTER FIX THREADED FUSION DEVICE2PMA Approval
- P970015LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC)2PMA Approval
- P950019RAY TFC UNITE PRODUCT LINE2PMA Approval
- P950002BAK VISTA INTERBODY FUSION DEVICE2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P970015INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P000028AFFINITY ANTERIOR CERVICAL CAGE SYSTEM2PMA Approval
- P970015LT-CAGE TAPERED FUSION DEVICE2PMA Approval
- P980048BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM2PMA Approval
- P000028AFFINITY (TM) CAGE SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE2PMA Approval
- P950019RAY TFC DEVICE/RAY TFC UNITE DEVICE2PMA Approval
- P970015DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE2PMA Approval
- P980048BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM2PMA Approval
- P980048BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM2PMA Approval
- P970015INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE2PMA Approval
- P970015LORDOTEC(TM) TAPERED FUSION DEVICE2PMA Approval
- P950019RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION2PMA Approval
- P950019RAY TFC DEVICE AND RAY TFC UNITE DEVICE2PMA Approval
- P950002BAK/L INTERBODY FUSION SYSTEM2PMA Approval
- P950019RAY THREADED FUSION CAGE(TFC)2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION2PMA Approval
- P970015INTER FIX THREADED FUSION DEVICE2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION2PMA Approval
- P950019RAY FUSION THREADED CAGE (TFC) DEVICE2PMA Approval
- P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS2PMA Approval
- P950019RAY TFC DEVICE INSTRUMENTATION2PMA Approval
- P950019RAY TFC DEVICE WITH INSTRUMENTATION2PMA Approval
- P950019RAY TFC DEVICE WITH INSTRUMENTATION (20MM)2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION2PMA Approval
- P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION2PMA Approval
- P950002BAK INTERBODY FUSION SYSTEM2PMA Approval
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SABLE Expandable Spacer
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192115
- 510(k) Type
- Traditional
- Applicant
- Globus Medical Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/14/2020
- Days to Decision
- 161 days
- Submission Type
- Summary