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
- 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
- K251829DeGen Medical Patient Specific Implant (PSI) System2Cleared 510(K)
- K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System2Cleared 510(K)
- K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer System2Cleared 510(K)
- K251644ProAM ALIF System2Cleared 510(K)
- K250845Curiteva Porous PEEK Standalone ALIF System2Cleared 510(K)
- K251459OneLIF™ Interbody Fusion System2Cleared 510(K)
- K243934Stable-L Lumbar Interbody System2Cleared 510(K)
- K243386Ventris Intervertebral Body Fusion Device2Cleared 510(K)
- K250603AxTiHA® Stand-Alone ALIF System2Cleared 510(K)
- K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation2Cleared 510(K)
- K243635aprevo® anterior lumbar interbody fusion device with interfixation2Cleared 510(K)
- K243191Atlas Spine Lateral Expandable Interbody System2Cleared 510(K)
- K241077DeGen Medical Patient Specific Implant (PSI) System2Cleared 510(K)
- K241992Catalyft™ LS Expandable Interbody System2Cleared 510(K)
- K241477aprevo® anterior lumbar interbody fusion device with interfixation2Cleared 510(K)
- K241487Interwedge® Standalone Lateral2Cleared 510(K)
- K241321Juliet® Ti LL Lumbar Interbody Device2Cleared 510(K)
- K240368E3D™-A Interbody System2Cleared 510(K)
- K240126ProAM ALIF System2Cleared 510(K)
- K240623Omnia Medical TiBrid™-SA System2Cleared 510(K)
- K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)2Cleared 510(K)
- K232432E3D™-A Interbody System2Cleared 510(K)
- K232123MectaLIF Anterior Lag Extension2Cleared 510(K)
- K231486Stable-L Standalone Lumbar Interbody System2Cleared 510(K)
- K232097IdentiTi ALIF Interbody Systems2Cleared 510(K)
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System2Cleared 510(K)
- K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation2Cleared 510(K)
- K230894NuVasive Modulus ALIF System2Cleared 510(K)
- K230731Zavation ALIF System2Cleared 510(K)
- K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System2Cleared 510(K)
- K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)2Cleared 510(K)
- K223413Pisces™-SA STANDALONE ALIF Interbody System2Cleared 510(K)
- K223146EVOLUTION SPINE Interbody System2Cleared 510(K)
- K222554EL CAPITAN Anterior Lumbar Interbody Fusion2Cleared 510(K)
- K222009aprevo® anterior lumbar interbody fusion device with interfixation2Cleared 510(K)
- K221545MectaLIF Anterior Extension2Cleared 510(K)
- K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device2Cleared 510(K)
- K221936Standalone ALIF Interbody Fusion System2Cleared 510(K)
- K221447Southern Anterior Screw Fixated Cage (SASCA)2Cleared 510(K)
- K222561Align2Cleared 510(K)
- K220610SOLO-L2Cleared 510(K)
- K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System2Cleared 510(K)
- K213935PISCES-SA Standalone ALIF Interbody System2Cleared 510(K)
- K211837Altus Spine Interbody Standalone Fusion System2Cleared 510(K)
- K213118Dakota ALIF System2Cleared 510(K)
- K214047EL CAPITAN Anterior Lumbar Interbody Fusion System2Cleared 510(K)
- K212498Stable-L Standalone Lumbar Interbody System2Cleared 510(K)
- K212980Tesera-k ALIF System2Cleared 510(K)
- K212967AxTiHA Stand-Alone ALIF System2Cleared 510(K)
- K210590Axis Spine Technologies ALIF2Cleared 510(K)
- K211769OneLIF Intervertebral Body Replacement System2Cleared 510(K)
- K201671A-Link Z2Cleared 510(K)
- K203742IdentiTi ALIF Standalone Interbody System2Cleared 510(K)
- K202032Idys LLIF 3DTi2Cleared 510(K)
- K210271NuVasive Modulus ALIF System2Cleared 510(K)
- K203207Omnia Medical TiBrid-SA2Cleared 510(K)
- K202230NEXXT MATRIXX Stand Alone ALIF System2Cleared 510(K)
- K202190Oculus-SA Lumbar Cage System2Cleared 510(K)
- K201585Monterey AL Interbody System2Cleared 510(K)
- K201087CORBEL Spacers2Cleared 510(K)
- K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device2Cleared 510(K)
- K200352Axis Spine Technologies ALIF2Cleared 510(K)
- K200541Hive™ Stand-alone Anterior Lumbar Interbody System2Cleared 510(K)
- K192492EL CAPITAN Anterior Lumber Interbody System2Cleared 510(K)
- K200338ProLift Lateral Fixated2Cleared 510(K)
- K193593NuVasive 3DP Interfixated ALIF System2Cleared 510(K)
- K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System2Cleared 510(K)
- K192993SCARLET AL-T2Cleared 510(K)
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device2Cleared 510(K)
- K191834Stand-Alone ALIF Titanium System2Cleared 510(K)
- K192168Idys ALIF ZP 3DTi2Cleared 510(K)
- K190179SAHARA Stabilization System2Cleared 510(K)
- K192054Endoskeleton TAS Plate2Cleared 510(K)
- K192047Rampart™ One Lumbar Interbody Fusion System2Cleared 510(K)
- K182139AXTi Titanium Stand-Alone ALIF System2Cleared 510(K)
- K191263Idys ALIF TiVac2Cleared 510(K)
- K190877Juliet® Ti LL Lumbar Interbody Device2Cleared 510(K)
- K191091Rampart One Lumbar Interbody Fusion System2Cleared 510(K)
- K183426MectaLIF Anterior Stand Alone Extension2Cleared 510(K)
- K181096Avenue P Cage System2Cleared 510(K)
- K181118Reliance Lumbar IBF System2Cleared 510(K)
- K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System2Cleared 510(K)
- K182195Arco™-SA Lumbar Cage System2Cleared 510(K)
- K181818Scarlet AL-T2Cleared 510(K)
- K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar System2Cleared 510(K)
- K181386NuVasive Brigade Lateral System2Cleared 510(K)
- K180814CoreLink® M3™ Stand-Alone Anterior Lumbar System2Cleared 510(K)
- K180695FBC 921 (ALIF)2Cleared 510(K)
- K180502S128 Anterior Lumbar Interbody Fusion (ALIF) System2Cleared 510(K)
- K180519HARRIER-SA™ Lumbar Interbody System2Cleared 510(K)
- K180002Rampart One Lumbar Interbody Fusion Device2Cleared 510(K)
- K173432ENZA-A Titanium ALIF2Cleared 510(K)
- K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device2Cleared 510(K)
- K173082Arco™-SA Lumbar Cage System2Cleared 510(K)
- K172941CASCADIA Interbody System2Cleared 510(K)
- K172019Brisbane ALIF Device, Gladstone ALIF Device2Cleared 510(K)
- K172083Idys™ ALIF System2Cleared 510(K)
- K172328SOVEREIGN™ Spinal System2Cleared 510(K)
- K170157INDEPENDENCE® Spacers2Cleared 510(K)
- K170855T-Rex Standalone ALIF2Cleared 510(K)
- K171567IRIX-A Lumbar Integrated Fusion System2Cleared 510(K)
- K163670Rampart One Lumbar Interbody Fusion Device2Cleared 510(K)
- K170592NuVasive BASE Interfixated Titanium System2Cleared 510(K)
- K162236Ax Stand-Alone ALIF System2Cleared 510(K)
- K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device2Cleared 510(K)
- K170455MectaLIF Anterior Stand Alone2Cleared 510(K)
- K163543Biomet Fusion System2Cleared 510(K)
- K162680SOVEREIGN® Spinal System2Cleared 510(K)
- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device2Cleared 510(K)
- K161993Leva® Anterior Interbody System2Cleared 510(K)
- K161379ELSA Spacers2Cleared 510(K)
- K161173Avenue® T TLIF Cage2Cleared 510(K)
- K161129PILLAR SA PTC2Cleared 510(K)
- K160597INDEPENDENCE MIS Spacers2Cleared 510(K)
- K160605MectaLIF Anterior Stand-Alone2Cleared 510(K)
- K161223TransContinental® M Spacers and InterContinental® Plate-Spacers2Cleared 510(K)
- K153720ENZA Zero-Profile Anterior Interbody Fusion2Cleared 510(K)
- K160051NuVasive® Interfixated Interbody System2Cleared 510(K)
- K160291Optimus ALIF System2Cleared 510(K)
- K151312VerteLP Interbody Fusion Device2Cleared 510(K)
- K151481Sahara Stabilization System2Cleared 510(K)
- K152943NuVasive Foundation-LL System2Cleared 510(K)
- K150673SYNFIX Evolution Secured Spacer System2Cleared 510(K)
- K151214ALIF Interfixated System2Cleared 510(K)
- K142645Avenue T TLIF Cage2Cleared 510(K)
- K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti2Cleared 510(K)
- K142487Chesapeake Stabilization System2Cleared 510(K)
- K143228Ancora LLC Interbody Fusion Device2Cleared 510(K)
- K142498MAGNIFY and MAGNIFY-S Spacers2Cleared 510(K)
- K141798SYPHER SPACER SYSTEM2Cleared 510(K)
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System2Cleared 510(K)
- K141187IMPIX ALIF S/A2Cleared 510(K)
- K142271Zavation Z-Link Lumbar2Cleared 510(K)
- K133827A-LINK Z2Cleared 510(K)
- K142066AERO-LL LUMBAR CAGE SYSTEM2Cleared 510(K)
- K141942MIDLINE II TI2Cleared 510(K)
- K142095RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM2Cleared 510(K)
- K141791BIOMET FUSION SYSTEM2Cleared 510(K)
- K133947IRIX-A LUMBAR INTEGRATED FUSION SYSTEM2Cleared 510(K)
- K140479COROENT XL-F SYSTEM2Cleared 510(K)
- K133494CHESAPEAKE SPINAL SYSTEM2Cleared 510(K)
- K133328AERO-AL LUMBAR CAGE SYSTEM2Cleared 510(K)
- K132596PROPOSED OPTIMUS2Cleared 510(K)
- K140106S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM2Cleared 510(K)
- K133286MIDLINE (TM)2Cleared 510(K)
- K131276LATERAL SYNFIX2Cleared 510(K)
- K132559MONUMENT SPACERS2Cleared 510(K)
- K131723COROENT SINGLE TAB SYSTEM2Cleared 510(K)
- K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM2Cleared 510(K)
- K130641LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K130461STALIF X2Cleared 510(K)
- K131547LANX FUSION SYSTEM2Cleared 510(K)
- K124034MECTALIF ANTERIOR2Cleared 510(K)
- K130445VAULT ALIF SYSTEM2Cleared 510(K)
- K123045BRIGADE STANDALONE SYSTEM2Cleared 510(K)
- K123767LANX FUSION SYSTEM- SA2Cleared 510(K)
- K123993SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM2Cleared 510(K)
- K112700FRONTIER SADL INTERBODY FUSION DEVICE2Cleared 510(K)
- K120869ANCHOR-L LUMBAR CAGE2Cleared 510(K)
- K122168VISUALIF CHALLENGING ACCESS PLATE2Cleared 510(K)
- K121982SOVEREIGN SPINAL SYSTEM2Cleared 510(K)
- K113285LDR SPINE USA AVENUE L INTERBODY FUSION2Cleared 510(K)
- K121211VU APOD INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K120101INDEPENDENCE SPACER2Cleared 510(K)
- K120557SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 352Cleared 510(K)
- K120031CHESAPEAKE SPINAL SYSTEM2Cleared 510(K)
- K112561NUVASIVE COROENT NO-PROFILE SYSTEM2Cleared 510(K)
- K110063SOVEREIGN SPINAL SYSTEM2Cleared 510(K)
- K110327LDR SPINE ROI-A INTERBODY FUSION SYSTEM2Cleared 510(K)
- K111626ENDOSKELETON(R) TAS2Cleared 510(K)
- K111122AESCULAP SIBD XP SPINAL SYSTEM2Cleared 510(K)
- K103382INTERCONTINENTAL PLATE-SPACER2Cleared 510(K)
- K103369VAULT ALIF SYSTEM2Cleared 510(K)
- K102402SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM2Cleared 510(K)
- K102738LANX FUSION SYSTEM2Cleared 510(K)
- K102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR2Cleared 510(K)
- K100516ANYPLUS PEEK CAGES2Cleared 510(K)
- K102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM2Cleared 510(K)
- K101310VU APOD INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K100802AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM2Cleared 510(K)
- K100043COROENT XLR STANDALONE SYSTEM2Cleared 510(K)
- K093808INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE2Cleared 510(K)
- K093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K092211CHESAPEAKE SPINAL SYSTEM2Cleared 510(K)
- K091301LIFE SPINE STAND-ALONE SPACER SYSTEM2Cleared 510(K)
- K091813INTREPID SPINAL SYSTEM2Cleared 510(K)
- K083475LUCENT MAGNUM2Cleared 510(K)
- K082926ZUMA, MODEL 55-XXXX/56-XXXX2Cleared 510(K)
- K082252INDEPENDENCE SPACER2Cleared 510(K)
- K081711LUCENT MAGNUM+2Cleared 510(K)
- K081849BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE2Cleared 510(K)
- K081501SOLITAIRE ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K080822VU APOD INTERVERTABRAL BODY FUSION DEVICE2Cleared 510(K)
- K081395SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K073109STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K072253SYNFIX-LR SPACER2Cleared 510(K)
- K071922INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC2Cleared 510(K)
- 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
PROPOSED OPTIMUS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K132596
- 510(k) Type
- Traditional
- Applicant
- Custom Spine, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/11/2014
- Days to Decision
- 235 days
- Submission Type
- Summary