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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
- 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
- K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System2Cleared 510(K)
- K242253JARVIS Glenoid Reverse Shoulder Prosthesis2Cleared 510(K)
- K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid2Cleared 510(K)
- K233482Equinoxe® Central Screw Baseplate System2Cleared 510(K)
- K233481AltiVate Reverse® Glenoid2Cleared 510(K)
- K241043Augment Off-Axis Instrument System2Cleared 510(K)
- K240278Full Wedge Lateralized and Augmented Baseplates2Cleared 510(K)
- K234105Catalyst F1x Shoulder System2Cleared 510(K)
- K233148Augment Off-Axis Instrument System2Cleared 510(K)
- K232265BLUEPRINT™ Patient Specific Instrumentation2Cleared 510(K)
- K231445LINK Embrace Shoulder System - Reverse Configuration2Cleared 510(K)
- K231911Glenoid Reconstruction System – Full Wedge Baseplate2Cleared 510(K)
- K232583Catalyst R1 Reverse Shoulder System2Cleared 510(K)
- K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays2Cleared 510(K)
- K232226ARROW Off-Centred Humeral Insert2Cleared 510(K)
- K223801FX V135(TM) Shoulder Prosthesis2Cleared 510(K)
- K223655Catalyst R1 Reverse Shoulder System2Cleared 510(K)
- K230366Arthrex Univers Revers Monoblock Stem Size 4/332Cleared 510(K)
- K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2Cleared 510(K)
- K223211INHANCETM Shoulder System – Humeral Stems and Stemless2Cleared 510(K)
- K213459Glenoid Reconstruction System2Cleared 510(K)
- K222936Humeris® 135 Shoulder System2Cleared 510(K)
- K220914Tornier Perform Humeral System – Fracture2Cleared 510(K)
- K221467INHANCETM Reverse Glenoid Peripheral Posts2Cleared 510(K)
- K213349Catalyst R1 Reverse Shoulder System2Cleared 510(K)
- K213117FX V135 Shoulder Prosthesis2Cleared 510(K)
- K212737INHANCE™ Reverse Shoulder System2Cleared 510(K)
- K212800PRIMA Humeral System and SMR Glenosphere Ø422Cleared 510(K)
- K202024ARROW Short Stem Humeral System2Cleared 510(K)
- K212992LINK® Embrace Shoulder System - Reverse Configuration2Cleared 510(K)
- K212415Arthrex Modular Glenoid System-Titanium Glenosphere2Cleared 510(K)
- K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation2Cleared 510(K)
- K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner2Cleared 510(K)
- K213124Tomier Perform™ Reversed Glenoid Cannulated Glenospheres2Cleared 510(K)
- K212710GLOBAL UNITE™ Platform Shoulder System2Cleared 510(K)
- K211074Univers Revers Modular Glenoid System, Standard Augment Baseplates2Cleared 510(K)
- K210790Lateralized and Augmented Baseplates2Cleared 510(K)
- K210533Inset Reverse Total Shoulder System2Cleared 510(K)
- K211553Tecomet Global Unite Short Stem Instrumentation2Cleared 510(K)
- K211991Catalyst R1 Reverse Shoulder System2Cleared 510(K)
- K203694DELTA XTEND Reverse Shoulder System2Cleared 510(K)
- K210717Bone Screws dia. 5,0 mm2Cleared 510(K)
- K203375OVOMotion Reverse Shoulder Arthroplasty System2Cleared 510(K)
- K210207Humeral Eccentric Reverse Metaphysis2Cleared 510(K)
- K203755Shoulder System - TiNbN Coating2Cleared 510(K)
- K210167DELTA XTEND Reverse Shoulder System2Cleared 510(K)
- K202232Comprehensive Vault Reconstruction System2Cleared 510(K)
- K202611Catalyst OrthoScience R1 Reverse Shoulder System2Cleared 510(K)
- K200368LINK Embrace Shoulder System - Reverse Configuration2Cleared 510(K)
- K202098GLOBAL UNITE™ Platform Shoulder System2Cleared 510(K)
- K200171SMR TT Augmented Glenoid System2Cleared 510(K)
- K200895Univers Revers Modular Glenoid System, Half Augment Baseplate2Cleared 510(K)
- K193175Lateralized Glenosphere2Cleared 510(K)
- K191146Humelock TiN Coated Glenosphere2Cleared 510(K)
- K193394Humeral Cup Stability & Humeral Cup 135/145o Stability2Cleared 510(K)
- K193373Comprehensive® Reverse Shoulder2Cleared 510(K)
- K192967Medacta Shoulder System2Cleared 510(K)
- K192855DELTA XTEND(TM) Reverse Shoulder System2Cleared 510(K)
- K192799Glenoid Baseplate with Screw2Cleared 510(K)
- K193098Exactech® Equinoxe® Reverse Shoulder Glenospheres2Cleared 510(K)
- K193099Anatomical Shoulder System2Cleared 510(K)
- K193372Univers Revers Modular Glenoid System (Augemented baseplates)2Cleared 510(K)
- K191960Arthrex Univers Revers Modular Glenoid System2Cleared 510(K)
- K190738MyShoulder Placement Guides2Cleared 510(K)
- K190588Integra TITAN Reverse Shoulder System2Cleared 510(K)
- K191746SMR TT Augmented Glenoid System2Cleared 510(K)
- K19220632mm Glenosphere and Humeral Cup2Cleared 510(K)
- K192448Delta Xtend Revers Shoulder System2Cleared 510(K)
- K191561Exactech Equinoxe Humeral Augmented Trays2Cleared 510(K)
- K183077Delta Xtend Reverse Shoulder System2Cleared 510(K)
- K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid2Cleared 510(K)
- K181826Glenoid Polyaxial Non-locking Screws2Cleared 510(K)
- K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap2Cleared 510(K)
- K181999Integra TITAN Reverse Shoulder System2Cleared 510(K)
- K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay2Cleared 510(K)
- K181611Comprehensive Reverse Shoulder System2Cleared 510(K)
- K180632Exactech Equinoxe Small Reverse Shoulder System2Cleared 510(K)
- K173717Integra TITAN Reverse Shoulder System2Cleared 510(K)
- K173900Arthrex Univers Revers Modular Glenoid System2Cleared 510(K)
- K180089Medacta Shoulder System Short Humeral Diaphysis2Cleared 510(K)
- K172371Arthrex UNIVERS REVERS COATED BASEPLATE2Cleared 510(K)
- K173411Comprehensive Segmental Revision System (SRS)2Cleared 510(K)
- K171789ARROW Reverse Porous Glenoid2Cleared 510(K)
- K170748GLOBAL UNITE Platform Shoulder System2Cleared 510(K)
- K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate2Cleared 510(K)
- K173073AltiVate Anatomic to Reverse Conversion Module2Cleared 510(K)
- K170414Arthrex Univers Revers Apex Humeral Stems2Cleared 510(K)
- K171058Medacta Shoulder System: Threaded Glenoid Baseplate2Cleared 510(K)
- K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid2Cleared 510(K)
- K170452Medacta Shoulder System2Cleared 510(K)
- K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System2Cleared 510(K)
- K163669Humeris Shoulder2Cleared 510(K)
- K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw2Cleared 510(K)
- K161120SMR TT Metal Back Glenoid, Bone Graft instruments2Cleared 510(K)
- K162726Exactech® Equinoxe® Preserve Stem2Cleared 510(K)
- K162455Humelock Reversed Shoulder2Cleared 510(K)
- K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid2Cleared 510(K)
- K161189Integra TITAN Reverse Shoulder System2Cleared 510(K)
- K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)2Cleared 510(K)
- K152966Aequalis Fx22Cleared 510(K)
- K150488Humelock II Reversible Shoulder System2Cleared 510(K)
- K150568ARROW Humeral stems size 6 and 162Cleared 510(K)
- K150458Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere2Cleared 510(K)
- K142778ARROW Reverse Shoulder long keel and short keel glenoid base2Cleared 510(K)
- K142863Univers Rivers Shoulder Prosthesis System2Cleared 510(K)
- K141345AEQUALIS FX22Cleared 510(K)
- K142139SMR 40MM GLENOSPHERE2Cleared 510(K)
- K141990ENCORE HUMERAL SHOULDER STEM2Cleared 510(K)
- K140478AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM2Cleared 510(K)
- K140652POROUS COATED COMPREHENSIVE FRACTURE STEMS2Cleared 510(K)
- K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K141006RSP HUMERAL SOCKET INSERT2Cleared 510(K)
- K133378ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K140904RSP MONOBLOCK STEM WITH P2 COATING, SIZE 62Cleared 510(K)
- K130550RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW2Cleared 510(K)
- K130895REUNION RSA SHOULDER SYSTEM2Cleared 510(K)
- K132285AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS2Cleared 510(K)
- K130390COMPREHENSIVE CONVERTIBLE GLENOID2Cleared 510(K)
- K131353COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE2Cleared 510(K)
- K132239COMPREHENSIVE REVERSE SHOULDER SCREWS2Cleared 510(K)
- K131575EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT2Cleared 510(K)
- K130661ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K121067EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE2Cleared 510(K)
- K122692ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS2Cleared 510(K)
- K122442DEPUY CTA REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K121183COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS2Cleared 510(K)
- K112193ARROW REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K120374SEVIIN REVERSE SHOULDER2Cleared 510(K)
- K120739AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K120174DEPUT DELTA XTEND REVERSE SHOULDER2Cleared 510(K)
- K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS2Cleared 510(K)
- K113254SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS2Cleared 510(K)
- K120121COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE2Cleared 510(K)
- K113069COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY2Cleared 510(K)
- K113523LIMACORPORATE SMR REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K113121COMPREHENSIVE REVERSE SHOULDER2Cleared 510(K)
- K112069RSP GLENOID BASEPLATE POROUS COATED2Cleared 510(K)
- K103251DUOCENTRIC REVERSED2Cleared 510(K)
- K112615AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K111735REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER2Cleared 510(K)
- K111629TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-0012Cleared 510(K)
- K110598SMR REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K111061REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)2Cleared 510(K)
- K110599AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K110708EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...2Cleared 510(K)
- K103208REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM2Cleared 510(K)
- K101996DEPUY GLOBAL UNITE SHOULDER SYSTEM2Cleared 510(K)
- K102951EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)2Cleared 510(K)
- K093803BIO-MODULAR REVERSE SHOLDER2Cleared 510(K)
- K101909EXACTECH EQUINOXE, PLATFORM FRACTURE STEM2Cleared 510(K)
- K100741REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/0122Cleared 510(K)
- K093275EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER2Cleared 510(K)
- K100142AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K092900EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM2Cleared 510(K)
- K092873REVERSE SHOULDER PROSTHESIS2Cleared 510(K)
- K082702EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY2Cleared 510(K)
- K081016SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K081059AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K080642COMPREHENSIVE REVERSE SHOULDER2Cleared 510(K)
- K073688EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW2Cleared 510(K)
- K073676DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP2Cleared 510(K)
- K072804COMPREHENSIVE RS SHOULDER SYSTEM2Cleared 510(K)
- K071948AEQUALIS REVERSED ADAPTER2Cleared 510(K)
- K071379DELTA XTEND REVERSE SHOULDER MODULAR STEM2Cleared 510(K)
- K063569EQUINOXE REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K062250DELTA XTEND REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K062116DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS2Cleared 510(K)
- K061439AEQUALIS REVERSED PROSTHESIS2Cleared 510(K)
- K060704ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM2Cleared 510(K)
- K053274ANATOMICAL SHOULDER INVERSE/REVERSE2Cleared 510(K)
- K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K052086ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER2Cleared 510(K)
- K051075ENCORE REVERSE SHOULDER PROSTHESIS2Cleared 510(K)
- K050315DELTA HUMERAL CUPS2Cleared 510(K)
- K041066ENCORE REVERSE SHOULDER PROSTHESIS2Cleared 510(K)
- K050316AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K041873AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K030941AEQUALIS REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K021478DELTA SHOULDER2Cleared 510(K)
- 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
Humelock TiN Coated Glenosphere
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191146
- 510(k) Type
- Traditional
- Applicant
- FX Shoulder USA, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/15/2020
- Days to Decision
- 442 days
- Submission Type
- Summary