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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
- K241260ACTIFY™ Unicondylar Knee System2Cleared 510(K)
- K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)2Cleared 510(K)
- K242746OvertureTi Knee Resurfacing SystemTM2Cleared 510(K)
- K232114TRIBRID® Unicompartmental Knee System2Cleared 510(K)
- K221292Uni Knee Resurfacing System2Cleared 510(K)
- K212870TLC Unicompartmental Knee System2Cleared 510(K)
- K220930Restoris Multi-Compartmental Knee System2Cleared 510(K)
- K211471Balanced Knee System Uni2Cleared 510(K)
- K213071MOTOTM Partial Knee & MOTO PFJ Systems Extension2Cleared 510(K)
- K212307BC Reflex Uni Knee System2Cleared 510(K)
- K211512VISIONAIRE UK Patient Matched Cutting Guides2Cleared 510(K)
- K211895BC Reflex Uni Knee System2Cleared 510(K)
- K203697BC Reflex Uni Knee System2Cleared 510(K)
- K203341ACS LD Uni FB Knee System2Cleared 510(K)
- K203099Triathlon PKR System2Cleared 510(K)
- K202207Materialise PKA Guide System2Cleared 510(K)
- K200433iBalance UKA Tibial Tray Implant2Cleared 510(K)
- K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill2Cleared 510(K)
- K191996BC Reflex Uni Knee System2Cleared 510(K)
- K191150Bodycad Unicompartmental Knee System2Cleared 510(K)
- K191211JOURNEY II Unicompartmental Knee System2Cleared 510(K)
- K191325EMPOWR Partial Knee2Cleared 510(K)
- K190085Journey II Unicompartmental Knee System2Cleared 510(K)
- K183029MOTO Partial Knee System2Cleared 510(K)
- K181302Bodycad Unicompartmental Knee System2Cleared 510(K)
- K173970Materialise PKA Guide System2Cleared 510(K)
- K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts2Cleared 510(K)
- K172650Materialise PKA Guide System2Cleared 510(K)
- K170344Tahoe Uni Knee System2Cleared 510(K)
- K161741GMK UNI2Cleared 510(K)
- K163700Bodycad Unicompartmental Knee System2Cleared 510(K)
- K162084MOTO Partial Knee System2Cleared 510(K)
- K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing2Cleared 510(K)
- K161592Persona Partial Knee System2Cleared 510(K)
- K160738ZUK Select Knee System2Cleared 510(K)
- K152315JOURNEY II Uni Tibial Base and Insert2Cleared 510(K)
- K132640IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K123380STRIDE UNICONDYLAR KNEE2Cleared 510(K)
- K122529ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE2Cleared 510(K)
- K121974CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K120262HLS UNI EVOLUTION & U-KNEETEC2Cleared 510(K)
- K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER2Cleared 510(K)
- K113038SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS2Cleared 510(K)
- K111916CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K102069JOURNEY UNICONDYLAR TIBIAL BASEPLATES2Cleared 510(K)
- K101206TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM2Cleared 510(K)
- K100197GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS2Cleared 510(K)
- K092441MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM2Cleared 510(K)
- K090024TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM2Cleared 510(K)
- K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM2Cleared 510(K)
- K082081MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III2Cleared 510(K)
- K081351MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT2Cleared 510(K)
- K080368MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II2Cleared 510(K)
- K073175JOURNEY UNICONDYLAR FEMORAL IMPLANT2Cleared 510(K)
- K073248MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K072586CONFORMIS UNI-CONDYLAR KNEE SYSTEM2Cleared 510(K)
- K072368CONFORMIS METAL BACKED TIBIAL COMPONENT2Cleared 510(K)
- K063432CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)2Cleared 510(K)
- K063782ACCIN UNI-KNEE SYSTEM2Cleared 510(K)
- K061779COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE2Cleared 510(K)
- K061011COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE2Cleared 510(K)
- K060670ACCIN UNI-KNEE SYSTEM2Cleared 510(K)
- K060017MAKO SURGICAL UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K050373UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS2Cleared 510(K)
- K043570UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD2Cleared 510(K)
- K033769EIUS UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K033363ZIMMER UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K032824STELKAST UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K022211HLS UNI EVOLUTION PROSTHESIS2Cleared 510(K)
- K011954SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE2Cleared 510(K)
- K010685MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)2Cleared 510(K)
- K992287FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K954186SLED UNICOMPARTMENT KNEE SYSTEM2Cleared 510(K)
- K952068ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES2Cleared 510(K)
- K942263MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K945613DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT2Cleared 510(K)
- K941606PRESERVATION UNICOMPARTMENTAL KNEE2Cleared 510(K)
- K931214P.C.A. MODULAR KNEE SYSTEM2Cleared 510(K)
- K926231DURACON UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K922824KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM2Cleared 510(K)
- K921232KEANE UNI KNEE SYSTEM WITH POROCOAT2Cleared 510(K)
- K915240NATURAL-KNEE TIBIAL AND FEMORAL SPACERS2Cleared 510(K)
- K912735GENESIS UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K914439P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL2Cleared 510(K)
- K910807KEANE UNI KNEE SYSTEM2Cleared 510(K)
- K910083OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES2Cleared 510(K)
- K903286CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION2Cleared 510(K)
- K900619CAAS UNICOMPARMENTAL KNEE SYSTEM2Cleared 510(K)
- K896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K896856MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS2Cleared 510(K)
- K894068KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K881779WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K880155MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE2Cleared 510(K)
- K873970KIRSCHNER UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K872735HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.2Cleared 510(K)
- K862632INSALL/BURSTEIN(TM)* II TIBIAL WEDGES2Cleared 510(K)
- K862837OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM2Cleared 510(K)
- K862136MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE2Cleared 510(K)
- K861715WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS2Cleared 510(K)
- K854325TRICON UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K853020POROCOAT SYNATOMIC UNICONDYLAR KNEE2Cleared 510(K)
- K853268FREEMAN UNI-COMPARTMENTAL KNEE2Cleared 510(K)
- K844706TRICON REVISION TOTAL KNEE SYSTEM2Cleared 510(K)
- K844355SYNATOMIC STANDARD TIBIAL PLATEAU2Cleared 510(K)
- K831513KENNEDY TIBIAL COMPONENT2Cleared 510(K)
- K803235GEO-TIBIAL RETAINER ROTATIONAL2Cleared 510(K)
- K800640MEDICAL COMPARTMENT KNEE PROSTHESIS2Cleared 510(K)
- K792240POLYCENTRIC TOTAL KNEE METAL TIBIAL2Cleared 510(K)
- K771511TOTAL KNEE PROSTHESIS-NONCONSTRAINED2Cleared 510(K)
- 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
- 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
VISIONAIRE UK Patient Matched Cutting Guides
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211512
- 510(k) Type
- Traditional
- Applicant
- Smith & Nephew, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/16/2021
- Days to Decision
- 125 days
- Submission Type
- Summary