Anesthesiology
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- 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
- 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
- K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion System2Cleared 510(K)
- K250335IVA & AEON Cervical and Lumbar Cage System2Cleared 510(K)
- K251080IdentiTi II Cervical Interbody System2Cleared 510(K)
- K250605EVOL® ha – Hyper C Cervical Interbody Fusion System2Cleared 510(K)
- K243915FIX-C 3D Ti ACIF System2Cleared 510(K)
- K243673Xenco Medical CancelleX Cervical Interbody System2Cleared 510(K)
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM2Cleared 510(K)
- K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System2Cleared 510(K)
- K242195Gemini Cervical Fusion Cage System2Cleared 510(K)
- K241738PYXIS 3D Titanium Cervical Cage system2Cleared 510(K)
- K240893ARTFX MEDICAL Cervical PEEK Cages2Cleared 510(K)
- K240838Spectrum Spine Cervical Cage System2Cleared 510(K)
- K241396uCerv Flux™-C 3D Porous Titanium Cervical Interbody2Cleared 510(K)
- K232619MATRIX HA PEEK Cervical IBF System2Cleared 510(K)
- K240416Tranquil-C Interbody System2Cleared 510(K)
- K231371BEE Cervical Cage2Cleared 510(K)
- K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system2Cleared 510(K)
- K230639Align Cervical Interbody Fusion System2Cleared 510(K)
- K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system2Cleared 510(K)
- K231836ClariVy™ Cervical IBF System2Cleared 510(K)
- K230478Acro Composites Interbody System2Cleared 510(K)
- K231899HAtetracell™-C Titanium Cervical IBF System2Cleared 510(K)
- K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)2Cleared 510(K)
- K231076VariLift®-C Interbody Fusion System2Cleared 510(K)
- K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical2Cleared 510(K)
- K232150ZSFab Cervical Interbody System2Cleared 510(K)
- K230607SPICCA Cervical Fusion Cages2Cleared 510(K)
- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR System2Cleared 510(K)
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System2Cleared 510(K)
- K222015Integral Titanium Cervical Interbody2Cleared 510(K)
- K230329F3D Interbody System2Cleared 510(K)
- K230936Anatomic PEEK™ Cervical Fusion System with Nanotechnology2Cleared 510(K)
- K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)2Cleared 510(K)
- K222833Ventana™ C Spinal System2Cleared 510(K)
- K230414ClariVy™ Cervical IBF System2Cleared 510(K)
- K222004INTEGRATE -C Interbody Fusion System2Cleared 510(K)
- K220513NITRO Interbody Fusion Cage System Family2Cleared 510(K)
- K220261NEST-C Interbody System2Cleared 510(K)
- K223513UniVy™ OsteoVy™-Ti Cervical IBF System2Cleared 510(K)
- K230026SQUALE2Cleared 510(K)
- K230583Tryptik Ti2Cleared 510(K)
- K223043The Integrity Spine Core System2Cleared 510(K)
- K223231Ti-Largo Cervical Interbody System2Cleared 510(K)
- K213755Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system2Cleared 510(K)
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer2Cleared 510(K)
- K213030Curiteva Porous PEEK Cervical Interbody Fusion System2Cleared 510(K)
- K212701Eminent Spine 3D Cervical Interbody Fusion System2Cleared 510(K)
- K220296Manta Ray TDF Spacer2Cleared 510(K)
- K223731NuVasive Modulus-C Interbody System2Cleared 510(K)
- K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device2Cleared 510(K)
- K222806Kodiak C Spinal Implant System2Cleared 510(K)
- K223510Matrix HA Fusion Porous Cervical IBF System2Cleared 510(K)
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem2Cleared 510(K)
- K221162UniVy OsteoVy Cervical IBF System2Cleared 510(K)
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments2Cleared 510(K)
- K222276CONDUIT Cages; FIBERGRAFT BG Putty2Cleared 510(K)
- K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF System2Cleared 510(K)
- K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody2Cleared 510(K)
- K212450Keos Anterior Cervical Interbody Fusion Device System2Cleared 510(K)
- K202266Reliance Cervical IBF System2Cleared 510(K)
- K213980Peridot Spinal Interbody System2Cleared 510(K)
- K213493Fortilink with TiPlus Technology2Cleared 510(K)
- K212266FIX-C PEEK Anterior Cervical Interbody System2Cleared 510(K)
- K212715Vy Spine ClariVy Cervical IBF System2Cleared 510(K)
- K213115CHENA-C Spacer System2Cleared 510(K)
- K211935ORIO-Ti Intervertebral Body Fusion Cage System2Cleared 510(K)
- K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage2Cleared 510(K)
- K201793EDEN Peek Cage2Cleared 510(K)
- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System2Cleared 510(K)
- K212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage2Cleared 510(K)
- K211501Advantage-C PEEK Cervical lnterbody Fusion Device2Cleared 510(K)
- K210521DEXA-C Cervical Interbody System2Cleared 510(K)
- K210890GPS Cervical Spacers2Cleared 510(K)
- K203520Blustone Synergy Interbody Fusion System2Cleared 510(K)
- K203444BEE HA Cage2Cleared 510(K)
- K203342CONSTRUX Mini Ti Spacer System2Cleared 510(K)
- K202872Prase PEEK Anterior Cervical Interbody Spacer2Cleared 510(K)
- K202398Ti3Z Cervical Interbody System2Cleared 510(K)
- K200429BEE Cages2Cleared 510(K)
- K202488ZSFab Cervical Interbody System2Cleared 510(K)
- K200458Tailored-C Cervical Interbody Fusion System2Cleared 510(K)
- K201643ChoiceSpine Tiger Shark Cervical Spacer System2Cleared 510(K)
- K200549Lucero Medical Cervical Cage System2Cleared 510(K)
- K202302Atlas Spine Rebar (Ti) Spacer System2Cleared 510(K)
- K202949CONSTRUX Mini PEEK Spacer System2Cleared 510(K)
- K202666CONSTRUX Mini PTC Spacer System2Cleared 510(K)
- K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System2Cleared 510(K)
- K201769Cavetto [MAX] Cervical Cage System2Cleared 510(K)
- K200592GS Medical AnyPlus PEEK Cage System2Cleared 510(K)
- K200685RIGEL 3DR Anterior Cervical Interbody Fusion System2Cleared 510(K)
- K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System2Cleared 510(K)
- K200312Tryptik Ti2Cleared 510(K)
- K192897icotec Cervical Cage2Cleared 510(K)
- K193359SureMAX Family of Cervical Spacers2Cleared 510(K)
- K1920444CIS Marlin PEEK ACIF Cage2Cleared 510(K)
- K191812ADI Cervical Interbody Fusion Device2Cleared 510(K)
- K192316Matrix HA PEEK Cervical Implant System2Cleared 510(K)
- K191822Nano FortiCore, FortiCore2Cleared 510(K)
- K192208CORNICE Cervical Spacer System2Cleared 510(K)
- K191537eCarbon IBDs2Cleared 510(K)
- K191243HEDRON Cervical Spacers2Cleared 510(K)
- K191354Ti3Z Cervical Interbody System2Cleared 510(K)
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device2Cleared 510(K)
- K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System2Cleared 510(K)
- K190291Addivation Medical Cervical Interbody System2Cleared 510(K)
- K190889Republic Spine Restore Cervical Interbody Fusion System2Cleared 510(K)
- K182608Oyster ACIF Cage2Cleared 510(K)
- K190618RIGEL PEEK Anterior Cervical Interbody Fusion System2Cleared 510(K)
- K190380nvc2Cleared 510(K)
- K183397ChoiceSpine Stealth Cervical Spacer System2Cleared 510(K)
- K190322SCARLET® AC-T Secured Anterior Cervical Cage2Cleared 510(K)
- K183083Shoreline Cervical Interbody RT System2Cleared 510(K)
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device2Cleared 510(K)
- K190067Velofix Interbody Fusion System2Cleared 510(K)
- K182477Cervical Spacer2Cleared 510(K)
- K182284Tyber Medical PT Interbody Spacer2Cleared 510(K)
- K180909REVEL Spacers2Cleared 510(K)
- K181140Axis Chena Cervical PEEK Spacer System2Cleared 510(K)
- K181590Neurostructures Cavetto® [MAX] Cervical Cage System2Cleared 510(K)
- K181229TirboLOX-C Cervical IBFD2Cleared 510(K)
- K181471ACCUFUSE Cervical System2Cleared 510(K)
- K181435ATEC Cervical Spacer System2Cleared 510(K)
- K181115CxHA PEEK Cervical IBF System2Cleared 510(K)
- K181261Curiteva Cervical Interbody Fusion System2Cleared 510(K)
- K180590Tyber Medical PT Interbody Spacer System2Cleared 510(K)
- K180364HD LifeSciences Cervical IBFD System2Cleared 510(K)
- K180674EVOL® ha-C Cervical Interbody Fusion System2Cleared 510(K)
- K172788MONET™ Anterior Cervical Interbody Fusion Cage System2Cleared 510(K)
- K180401TiWAVE-C™ Porous Titanium Cervical Cage2Cleared 510(K)
- K180675Atlas Spine Expandable Cervical Interbody System2Cleared 510(K)
- K173722PATRIOT COLONIAL Spacer, SUSTAIN Spacer2Cleared 510(K)
- K173832InTice™-C Porous Ti Cervical Interbody System2Cleared 510(K)
- K172480icotec Interbody Cage System2Cleared 510(K)
- K172568Cervage2Cleared 510(K)
- K173128Alamo® C2Cleared 510(K)
- K173453Valeo® C+CSC with Lumen Interbody Fusion Device2Cleared 510(K)
- K173324ALTA Anterior Cervical Interbody Spacer2Cleared 510(K)
- K172320Neurostructures Cavetto® Cervical Cage System2Cleared 510(K)
- K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device2Cleared 510(K)
- K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™2Cleared 510(K)
- K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device2Cleared 510(K)
- K173102Reliance Cervical IBF System2Cleared 510(K)
- K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical2Cleared 510(K)
- K172185Tyber Medical PT Interbody Spacer System2Cleared 510(K)
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS2Cleared 510(K)
- K172676NuVasive® Modulus-C Interbody System2Cleared 510(K)
- K173148ACIF2Cleared 510(K)
- K173030Vertera Spine Cohere Cervical Interbody Fusion Device2Cleared 510(K)
- K172253Altus Spine Cervical Interbody Fusion System2Cleared 510(K)
- K172446SPIRA-C Open Matrix Cervical Interbody2Cleared 510(K)
- K172674Sapphire Cervical Implant System2Cleared 510(K)
- K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System2Cleared 510(K)
- K172065SCARLET AC-T2Cleared 510(K)
- K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers2Cleared 510(K)
- K163422Shanghai Sanyou PEEK Cage System2Cleared 510(K)
- K172489Reliance Cervical IBF System2Cleared 510(K)
- K171496Tritanium C Anterior Cervical Cage2Cleared 510(K)
- K171140Matrixx System2Cleared 510(K)
- K171075Calix-C Cervical Interbody Spacer2Cleared 510(K)
- K171749Velofix(tm) Interbody Fusion System2Cleared 510(K)
- K170550Coveris Cervical Cage System2Cleared 510(K)
- K170318NeoFuse Ti3D PLIF/TLIF/Cervical Interbody2Cleared 510(K)
- K171046SeaSpine Cambria System2Cleared 510(K)
- K170844Gemini-C Hybrid Cervical Interbody System2Cleared 510(K)
- K163494Summit Spine Channel Cervical Interbody Fusion System2Cleared 510(K)
- K162682MATISSE Anterior Cervical Interbody Fusion Cage System2Cleared 510(K)
- K163673Fortilink™-C with TETRAfuse™ 3D Technology2Cleared 510(K)
- K162496Foundation 3D Interbody2Cleared 510(K)
- K163265Kepler II2Cleared 510(K)
- K163491NuVasive CoRoent Small Interbody System2Cleared 510(K)
- K1624024CIS® Marlin ACIF Cage System2Cleared 510(K)
- K162587ROCCIA® ACIF2Cleared 510(K)
- K170074nvc2Cleared 510(K)
- K162694Ayers Rock Cervical interbody fusion system2Cleared 510(K)
- K161127The Small PLATEAU (PLATEAU-C) Spacer System2Cleared 510(K)
- K162003IMSE Cervical Cage2Cleared 510(K)
- K160222OIC Cervical PEEK Spacer2Cleared 510(K)
- K161809ShurFit CpTi-HA ACIF Interbody Fusion System2Cleared 510(K)
- K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage2Cleared 510(K)
- K161649Virtu C Spinal Implant System2Cleared 510(K)
- K162138NuVasive CoRoent Small Ti-C System2Cleared 510(K)
- K161642CAVUX™ Cervical Cage2Cleared 510(K)
- K161608InterForm Cervical Interbody Cage System2Cleared 510(K)
- K161407Ascential IBD PEEKc Spacer2Cleared 510(K)
- K153517AnyPlus® Cervical PEEK Cage System2Cleared 510(K)
- K160154ALTA Anterior Cervical Interbody Spacer2Cleared 510(K)
- K160324Cervical Interbody Fusion System2Cleared 510(K)
- K160125Cascadia Interbody System2Cleared 510(K)
- K160528ANATOMIC PEEK PTC Cervical Fusion System2Cleared 510(K)
- K153438PERIMETER C (Titanium) Spinal System2Cleared 510(K)
- K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device2Cleared 510(K)
- K152532AERO -C Cervical Cage System2Cleared 510(K)
- K151496Latitude-C Cervical Interbody Spacer System2Cleared 510(K)
- K152987Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System2Cleared 510(K)
- K150455RT2 Trabeculite Titanium Cervical Cage System2Cleared 510(K)
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices2Cleared 510(K)
- K143685Hedgehog Cervical Interbody Fusion Device2Cleared 510(K)
- K143450Ackermann Intervertebral Body Fusion Device2Cleared 510(K)
- K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System2Cleared 510(K)
- K152302Xenco Medical Cervical Interbody System (Argus)2Cleared 510(K)
- K150812Genesys Spine Apache Cervical Interbody Fusion System2Cleared 510(K)
- K150847Foundation Interbody Devices2Cleared 510(K)
- K151677LnK Cervical Interbody Fusion Cage System2Cleared 510(K)
- K150362NuVasive CoRoent Small Interbody System2Cleared 510(K)
- K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK2Cleared 510(K)
- K142269Reliance Cervical IBF System2Cleared 510(K)
- K150130Ascendant TM Cervical Spacer System2Cleared 510(K)
- K142586Captiva Spine FuselOX Cervical IBF System2Cleared 510(K)
- K150521Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System2Cleared 510(K)
- K142744Mecta-C TiPEEK2Cleared 510(K)
- K142456GPS Spacers2Cleared 510(K)
- K143360LnK Cervical Interbody Fusion Cage System2Cleared 510(K)
- K142218Coalition AGX Plate and Coalition AGX Spacer2Cleared 510(K)
- K142345Talos-C(HA) Cervical Intervertebral Body Fusion Devices2Cleared 510(K)
- K142152CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM2Cleared 510(K)
- K142328nvc2Cleared 510(K)
- K142041POROSTEON PHUSION METAL CERVICAL CAGE2Cleared 510(K)
- K142264Valeo C Spacer System, Valeo II C IBF Device2Cleared 510(K)
- K141333ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K142251AVS AS PEEK Spacer2Cleared 510(K)
- K142050NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM2Cleared 510(K)
- K142026SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K142450DIVERGENCE Anterior Cervical Fusion System2Cleared 510(K)
- K141337ARENA-C2Cleared 510(K)
- K140280FORTICORE2Cleared 510(K)
- K140786XENCO MEDICAL CERVICAL INTERBODY SYSTEM2Cleared 510(K)
- K141129EXACTECH CERVICAL SPACER SYSTEM2Cleared 510(K)
- K140921COROENT SMALL INTERBODY SYSTEM2Cleared 510(K)
- K140864VELOXTM INTERBODY FUSION SYSTEM2Cleared 510(K)
- K132732MEDYSSEY ANTERIOR CERVICAL FUSION CAGE2Cleared 510(K)
- K133784VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION2Cleared 510(K)
- K140066INFILL CERVICAL2Cleared 510(K)
- K133653ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM2Cleared 510(K)
- K133815INTESS CERVICAL CAGE SYSTEM2Cleared 510(K)
- K140003COROENT SMALL INTERBODY SYSTEM2Cleared 510(K)
- K132483INNESIS PEEK CERVICAL CAGE2Cleared 510(K)
- K133529CAMBER SPINE COVERIS CERVICAL CAGE2Cleared 510(K)
- K132926VELOFIXTM INTERBODY FUSION SYSTEM2Cleared 510(K)
- K132991C-BOX PEEK CERVICAL IBF2Cleared 510(K)
- K133623C-PLUS2Cleared 510(K)
- K133321ALAMO C2Cleared 510(K)
- K130317GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM2Cleared 510(K)
- K132584PERIMETER C SPINAL SYSTEM2Cleared 510(K)
- K132718INTEGRITY SPINE CORE SYSTEM2Cleared 510(K)
- K130853IDYS(TM) C2Cleared 510(K)
- K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF2Cleared 510(K)
- K131429RELIANCE CERVICAL IBF SYSTEM2Cleared 510(K)
- K130177ANATOMIC PEEK CERVICAL FUSION SYSTEM2Cleared 510(K)
- K130948C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K121178TRANSCORP ACIF SYSTEM2Cleared 510(K)
- K122588VUSION CS PLUS2Cleared 510(K)
- K122801PROVIDENCE CERVICAL CAGE2Cleared 510(K)
- K123909AESCULAP CESPACE XP2Cleared 510(K)
- K122850TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES2Cleared 510(K)
- K122872INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K122518SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE2Cleared 510(K)
- K123206MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM2Cleared 510(K)
- K120603VARILIFT -C2Cleared 510(K)
- K123388K7C SPACER2Cleared 510(K)
- K121649CONSTRUX MINI PEEK TI SPACER SYSTEM2Cleared 510(K)
- K1217414-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)2Cleared 510(K)
- K122085STINGRAY CERVICAL CAGE2Cleared 510(K)
- K122366TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE2Cleared 510(K)
- K122444CERVICAL CAGE2Cleared 510(K)
- K120486AVS AS PEEK SPACER2Cleared 510(K)
- K121320C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE2Cleared 510(K)
- K121569MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM2Cleared 510(K)
- K120345HONOUR SPACER SYSTEM2Cleared 510(K)
- K120275SYNTHES ACIS/VERTEBRAL SPACER CR2Cleared 510(K)
- K120840LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM2Cleared 510(K)
- K120396RELIANCE CERVICAL IBF SYSTEM2Cleared 510(K)
- K112801AYERS ROCK CERVICAL CAGE2Cleared 510(K)
- K120517DEPUY PULSE CERVICAL CAGE SYSTEM2Cleared 510(K)
- K111820SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE2Cleared 510(K)
- K120143ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL2Cleared 510(K)
- K113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K113559LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS2Cleared 510(K)
- K112664ZAVATION IBF SYSTEMS2Cleared 510(K)
- K112862MECTA-C2Cleared 510(K)
- K111123VARILIFT CERVICAL INTERBODY FUSION SYSTEM2Cleared 510(K)
- K112361ALAMO C2Cleared 510(K)
- K111119TRABECULAR METAL (TM) FUSION DEVICE2Cleared 510(K)
- K111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX2Cleared 510(K)
- K112444ANATOMIC PEEK CERVICAL FUSION SYSTEM2Cleared 510(K)
- K110442NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K112036CALIX PC SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K111264CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM2Cleared 510(K)
- K111484DISCOVERY2Cleared 510(K)
- K110733DAYTONA ANTERIOR CERVICAL CAGE2Cleared 510(K)
- K100967PERIMETER C SPINAL SYSTEM2Cleared 510(K)
- K111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K110915CERVICAL CAGE2Cleared 510(K)
- K111835PLATEAU SPACER SYSTEM2Cleared 510(K)
- K103655OCTANE-C INTERBODY FUSION DEVICE SYSTEM2Cleared 510(K)
- K110585CAPTIVA SPINE FUSELOX CERVICAL CAGE2Cleared 510(K)
- K100698STCC2Cleared 510(K)
- K103169ALEUTTIAN2Cleared 510(K)
- K103660LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K102449BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM2Cleared 510(K)
- K101171ORTHOVITA PEEK SPACER2Cleared 510(K)
- K103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX2Cleared 510(K)
- K101363VU CPOD INTERVERTEBRAL BODU FUSION DEVICE2Cleared 510(K)
- K093093SMALL PLATEAU SPACER SYSTEM2Cleared 510(K)
- K101812CONSTRUX MINI PEEK SPACER SYSTEM2Cleared 510(K)
- K092794TRANSCORP ACIF SYSTEM2Cleared 510(K)
- K100889ENDOSKELETON TC2Cleared 510(K)
- K101302ALEUTIAN IBF SYSTEM2Cleared 510(K)
- K100214CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE2Cleared 510(K)
- K100484IMPIX MANTA CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER2Cleared 510(K)
- K092904PATHWAY IVB/VBR2Cleared 510(K)
- K091531CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER2Cleared 510(K)
- K090887ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES2Cleared 510(K)
- K091873TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S2Cleared 510(K)
- K082848NUBIC AND RABEA DEVICES2Cleared 510(K)
- K091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEM2Cleared 510(K)
- K083118SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE2Cleared 510(K)
- K083637CALIX SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K082309CAMBRIA2Cleared 510(K)
- K083425FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE2Cleared 510(K)
- K083311AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K083167PHENIX CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K082801PHANTOM PLUS CAGE SYSTEM2Cleared 510(K)
- K081880ATLAS SPINE SPACER2Cleared 510(K)
- K081611NUVASIVE COROENT SYSTEM2Cleared 510(K)
- K081730NOVEL CERVICAL SPINAL SPACER SYSTEM2Cleared 510(K)
- K081614ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES2Cleared 510(K)
- K073320CIMPLICITY SPINAL SYSTEM2Cleared 510(K)
- K073351CRYSTAL2Cleared 510(K)
- K072991PATRIOT SPACERS: COLONIAL ACDF2Cleared 510(K)
- 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
Shoreline Cervical Interbody RT System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K183083
- 510(k) Type
- Traditional
- Applicant
- SeaSpine Orthopedics Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/14/2019
- Days to Decision
- 100 days
- Submission Type
- Summary