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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
- 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
- K252322SIros-X System2Cleared 510(K)
- K253094iFuse Bedrock Granite Implant System2Cleared 510(K)
- K250894Eminent Spine Posterior SI System2Cleared 510(K)
- K250647SImmetry+ System2Cleared 510(K)
- K250247panaSIa SI Fusion System2Cleared 510(K)
- K251395The Rialto™ SI Fusion System2Cleared 510(K)
- K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System2Cleared 510(K)
- K242431Omnia Medical PsiF DNA™ System2Cleared 510(K)
- K250001Patriot SI Implant System2Cleared 510(K)
- K251075DYNAMIS™ Implant System2Cleared 510(K)
- K250403Catamaran SI Joint Fusion System2Cleared 510(K)
- K243838NEXXT MATRIXX® SI System2Cleared 510(K)
- K243565DYNAMIS™ SI Screw System2Cleared 510(K)
- K243835TiLink-P SI Joint Fusion System2Cleared 510(K)
- K242414TiLink-P Joint Fusion System2Cleared 510(K)
- K242141TiLink-P SI Joint Fusion System2Cleared 510(K)
- K241504iFuse TORQ TNT™ Implant System2Cleared 510(K)
- K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System2Cleared 510(K)
- K241464ARx® SAI Implant System2Cleared 510(K)
- K241574iFuse TORQ® Implant System2Cleared 510(K)
- K240505Eminent Spine SI Screw System2Cleared 510(K)
- K232149BowTie™ SI Joint Fusion System2Cleared 510(K)
- K232259Patriot-SI Posterior Implant System2Cleared 510(K)
- K240720TiLink-P SI Joint Fusion System2Cleared 510(K)
- K233972Camber Sacroiliac (SI) Fixation System2Cleared 510(K)
- K240201PathLoc SI Joint Fusion System2Cleared 510(K)
- K233508iFuse Bedrock Granite® Implant System2Cleared 510(K)
- K230817TORPEDO Implant System®2Cleared 510(K)
- K231923Liberty SI Lateral Implant System2Cleared 510(K)
- K233241SOLACE Sacroiliac Fixation System2Cleared 510(K)
- K232211REUNION Sacroiliac Joint Fusion System2Cleared 510(K)
- K232878TransLoc 3D2Cleared 510(K)
- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System2Cleared 510(K)
- K230857TiLink-P SI Joint Fusion System2Cleared 510(K)
- K230226Integrity-SI® Fusion System2Cleared 510(K)
- K231944CATAMARAN SI Joint Fusion System2Cleared 510(K)
- K231829Xenix Medical Sacroiliac Fixation System2Cleared 510(K)
- K231831TiLink-L Joint Fusion System2Cleared 510(K)
- K231951SI-Cure Sacroiliac Joint Fusion System2Cleared 510(K)
- K231841PathLoc SI Joint Fusion System2Cleared 510(K)
- K231689iFuse TORQ® Implant System2Cleared 510(K)
- K230446TiLink-L SI Joint Fusion System2Cleared 510(K)
- K220274Kisar Stratford SI Screw System2Cleared 510(K)
- K230689T-FIX™ 3DSI Joint Fusion System2Cleared 510(K)
- K213815SiJoin®T32Cleared 510(K)
- K223708Entasis 3D Dual-Lead Sacroiliac Implant System2Cleared 510(K)
- K223521ZESPIN SI Joint Fusion System2Cleared 510(K)
- K223819SI-Cure Sacroiliac Joint Fusion System2Cleared 510(K)
- K222774iFuse Bedrock Granite® Implant System2Cleared 510(K)
- K211785CASSATT™ SIJ Fixation System2Cleared 510(K)
- K222448UNITY Sacroiliac Joint Fixation System2Cleared 510(K)
- K221047SILO TFX MIS Sacroiliac Joint Fixation System2Cleared 510(K)
- K222605iFuse TORQ® Implant System2Cleared 510(K)
- K222512Integrity-SI Fusion System2Cleared 510(K)
- K203503Camber Sacroiliac (SI) Fixation System2Cleared 510(K)
- K211496TransLoc 3D2Cleared 510(K)
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System2Cleared 510(K)
- K214123T-FIX® 3DSI Joint Fusion System2Cleared 510(K)
- K213667iFuse-TORQ® Implant System2Cleared 510(K)
- K220195iFuse Bedrock Granite™ Implant System2Cleared 510(K)
- K212962TRELLIS™ SI Joint Fusion System2Cleared 510(K)
- K213590Blue Topaz Sacroiliac Screw System2Cleared 510(K)
- K212903SIMPACT Sacroiliac Joint Fixation System2Cleared 510(K)
- K210402Curiteva Sacroiliac Joint Fusion System2Cleared 510(K)
- K211449Triton™ Sacroiliac Joint Fixation System2Cleared 510(K)
- K210667FIREBIRD SI Fusion System2Cleared 510(K)
- K203780Harvester SI: Sacroiliac Fixation System2Cleared 510(K)
- K203247iFuse-TORQ™ Implant System2Cleared 510(K)
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System2Cleared 510(K)
- K203373Advanced Research Medical Trident SI Screw System2Cleared 510(K)
- K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System2Cleared 510(K)
- K203138FIREBIRD SI Fusion System2Cleared 510(K)
- K201538Life Spine SIMPACT Sacroiliac Joint Fixation System2Cleared 510(K)
- K201664FIREBIRD SI Fusion System2Cleared 510(K)
- K190580NADIA SI Fusion System2Cleared 510(K)
- K200868SI-Restore Sacroiliac Joint Fixation System2Cleared 510(K)
- K200696FIREBIRD SI Fusion System2Cleared 510(K)
- K193524SI-BONE iFuse Implant System®2Cleared 510(K)
- K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System2Cleared 510(K)
- K191748Genesys Spine Sacroiliac Joint Fusion System2Cleared 510(K)
- K190025EVOL® -SI Joint Fusion System2Cleared 510(K)
- K183342SambaScrew 3D SI Fusion System2Cleared 510(K)
- K190230iFuse Implant System®2Cleared 510(K)
- K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments2Cleared 510(K)
- K182919SI-Restore® Sacroiliac Joint Fixation System2Cleared 510(K)
- K182983iFuse Implant System®2Cleared 510(K)
- K181881Outlet Sacroiliac Joint Fusion System2Cleared 510(K)
- K181600PathLoc-SI Joint Fusion System2Cleared 510(K)
- K180749Life Spine SIMPACT Sacroiliac Joint Fixation System2Cleared 510(K)
- K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)2Cleared 510(K)
- K173201UNITY Sacroiliac Joint Fixation System2Cleared 510(K)
- K173752SI Screw System2Cleared 510(K)
- K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System2Cleared 510(K)
- K170475SICAGE™ System2Cleared 510(K)
- K162733iFuse Implant System® - iFuse-3D implant2Cleared 510(K)
- K162121Siconus SI Joint Fixation System2Cleared 510(K)
- K161755Integrity-SI TM Fusion System2Cleared 510(K)
- K153656PathLoc-SI Joint Fusion System2Cleared 510(K)
- K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems2Cleared 510(K)
- K160652iFUSE Implant System2Cleared 510(K)
- K152681iFuse Implant System(R)2Cleared 510(K)
- K152237The Entasis Dual-Lead Sacroiliac Implant2Cleared 510(K)
- K151718iFuse Implant System2Cleared 510(K)
- K151462SI-TECHNOLOGY® SI-DESIS® SCREWS2Cleared 510(K)
- K151818SImmetry Sacroiliac Joint Fusion System2Cleared 510(K)
- K150875iFuse Implant System2Cleared 510(K)
- K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System2Cleared 510(K)
- K150714SI-BONE iFuse Implant System2Cleared 510(K)
- K141246LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM2Cleared 510(K)
- K141549SImmetry Sacroiliac Joint Fusion System2Cleared 510(K)
- K141106FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM2Cleared 510(K)
- K141049IFUSE IMPLANT SYSTEM2Cleared 510(K)
- K140079SILEX SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K131405IFUSE IMPLANT SYSTEM2Cleared 510(K)
- K123850IFUSE IMPLANT SYSTEM2Cleared 510(K)
- K123702SILEX SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K130092SIMMETRY SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K122074IFUSE IMPLANT SYSTEM2Cleared 510(K)
- K110472SI-FIX SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K111801SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K110838IFUSE IMPLANT SYSTEM2Cleared 510(K)
- K110512SIMMETRY SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K102907SIMMETRY SACROILIAC JOINT FUSION SYSTEM2Cleared 510(K)
- K092375MODIFICATION TO SI JOINT FUSION SYSTEM2Cleared 510(K)
- K080398SI JOINT FUSION SYSTEM2Cleared 510(K)
- K051296SIJF CANNULATED SCREW SYSTEM2Cleared 510(K)
- 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
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161210
- 510(k) Type
- Traditional
- Applicant
- Medtronic Sofamor Danek
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/2016
- Days to Decision
- 106 days
- Submission Type
- Summary