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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
- K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)2Cleared 510(K)
- K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components2Cleared 510(K)
- K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella2Cleared 510(K)
- K250980Physica System (Physica CR Porous Femoral components)2Cleared 510(K)
- K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System2Cleared 510(K)
- K241597Freedom® Total Knee System - Porous Tibial Base Plate2Cleared 510(K)
- K243293Zimmer® Persona® Personalized Knee System2Cleared 510(K)
- K243615Physica Porous Femoral Components2Cleared 510(K)
- K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)2Cleared 510(K)
- K242412Agility Symmetric™ Total Knee System2Cleared 510(K)
- K243247Persona the Personalized Knee System2Cleared 510(K)
- K240393Exactech® TRULIANT® Knee System2Cleared 510(K)
- K240938The Optimotion™ Blue Plus Knee System2Cleared 510(K)
- K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology2Cleared 510(K)
- K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)2Cleared 510(K)
- K233507EVOLUTION® Tibial Cones2Cleared 510(K)
- K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology2Cleared 510(K)
- K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts2Cleared 510(K)
- K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System2Cleared 510(K)
- K230295ATTUNE® Revision Cones2Cleared 510(K)
- K221705U2 Total Knee System-PF+2Cleared 510(K)
- K223548GMK Sphere & GMK SpheriKA Cementless2Cleared 510(K)
- K222566Zimmer Persona Personalized Knee System2Cleared 510(K)
- K212746ATTUNE Revision Cones2Cleared 510(K)
- K221850GMK 3D Metal Tibial Tray2Cleared 510(K)
- K220049Optimotion Implants Porous Metal-Backed Patella2Cleared 510(K)
- K212941Porous Patella2Cleared 510(K)
- K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP2Cleared 510(K)
- K213817MPO Knee Instruments; MPO PROPHECY Knee Instruments2Cleared 510(K)
- K211221Porous Patella and Porous Tibia Baseplate2Cleared 510(K)
- K203779Symmetric Total Knee System2Cleared 510(K)
- K211246LEGION CR Porous Plus HA Femoral Components2Cleared 510(K)
- K210554Physica system2Cleared 510(K)
- K210308EMPOWR Porous Femur with HAnano SurfaceTM2Cleared 510(K)
- K210566LEGION Porous CR Narrow Femoral Components2Cleared 510(K)
- K201084Physica system2Cleared 510(K)
- K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology2Cleared 510(K)
- K193312UNIKO PointCloud™ Knee Instruments2Cleared 510(K)
- K201364LINK TrabecuLink Femoral Cones2Cleared 510(K)
- K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite2Cleared 510(K)
- K191084The Optimotion Blue Total Knee System2Cleared 510(K)
- K200113LINK TrabecuLink Tibial Cones2Cleared 510(K)
- K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment2Cleared 510(K)
- K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws2Cleared 510(K)
- K181794Truliant Porous Femoral Components2Cleared 510(K)
- K172524Zimmer Persona Personalized Knee System2Cleared 510(K)
- K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System2Cleared 510(K)
- K173849Triathlon Total Knee System2Cleared 510(K)
- K173417Zimmer Persona Personalized Knee System2Cleared 510(K)
- K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components2Cleared 510(K)
- K171365Arthrex Knee Systems2Cleared 510(K)
- K171991EMPOWR Porous Knee System2Cleared 510(K)
- K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell2Cleared 510(K)
- K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous2Cleared 510(K)
- K153657Vanguard XP Knee System2Cleared 510(K)
- K153776Optetrak One Logic Femoral Components2Cleared 510(K)
- K153586Arthrex iBalance TKA System2Cleared 510(K)
- K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base2Cleared 510(K)
- K152252Arthrex iBalance TKA System2Cleared 510(K)
- K150832U2 Femoral Component, CR, Porous Coated, Additional Sizes2Cleared 510(K)
- K150680Freedom Cementless Femoral Component2Cleared 510(K)
- K150090Zimmer Persona Personalized Knee System2Cleared 510(K)
- K140881DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS2Cleared 510(K)
- K143366ADVANCE Porous Coated Spiked Tibial Base2Cleared 510(K)
- K143393Triathlon Tritanium Cone Augments2Cleared 510(K)
- K141407VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL2Cleared 510(K)
- K141840TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH2Cleared 510(K)
- K141635ARTHREX IBALANCE TKA SYSTEM2Cleared 510(K)
- K140735EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS2Cleared 510(K)
- K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS2Cleared 510(K)
- K140883VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT2Cleared 510(K)
- K140302OPTETRAK LOGIC POROUS FEMORAL COMPONENTS2Cleared 510(K)
- K140075U2 FEMORAL COMPONENT, CR, POROUS COATED2Cleared 510(K)
- K140257SIGNATURE PLANNER, SIGNATURE GUIDES2Cleared 510(K)
- K132873VANGUARD XP KNEE SYSTEM2Cleared 510(K)
- K132624TRIATHLON TRITANIUM METAL-BACKED PATELLA2Cleared 510(K)
- K123486TRIATHLON TRITANIUM TIBIAL BASEPLATE2Cleared 510(K)
- K122218ADVANCE TOTAL KNEE SYSTEM-PATELLA2Cleared 510(K)
- K122160VANGUARD XP KNEE SYSTEM2Cleared 510(K)
- K123459ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM2Cleared 510(K)
- K122745ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM2Cleared 510(K)
- K121771ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM2Cleared 510(K)
- K122053SHAPEMATCH CUTTING GUIDE2Cleared 510(K)
- K121393SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION2Cleared 510(K)
- K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL2Cleared 510(K)
- K103598PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES2Cleared 510(K)
- K110950CONSENSUS KNEE SYSTEM2Cleared 510(K)
- K110533STRYKER PATIENT SPECIFIC CUTTING GUIDE2Cleared 510(K)
- K103517TRABECULAR METAL FEMORAL CONE AUGMENTS2Cleared 510(K)
- K102927CONSENSUS KNEE SYSTEM2Cleared 510(K)
- K102896TRABECULAR METAL TIBIAL CONE AUGMENTS2Cleared 510(K)
- K093405PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES2Cleared 510(K)
- K100897LEGION POROUS + HA TIBIAL BASEPLATES2Cleared 510(K)
- K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.02Cleared 510(K)
- K091543LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS2Cleared 510(K)
- K083782REGENEREX PATELLA COMPONENTS2Cleared 510(K)
- K081479ADVANCE A-CLASS TIBIAL INSERT2Cleared 510(K)
- K080842APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]2Cleared 510(K)
- K080361REGENEREX TIBIAL COMPONENTS2Cleared 510(K)
- K072575TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE2Cleared 510(K)
- K073325LEGION POROUS PRIMARY2Cleared 510(K)
- K072619NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS2Cleared 510(K)
- K072160NEXGEN TRABECULAR METAL TIBIAL TRAY2Cleared 510(K)
- K071790GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM2Cleared 510(K)
- K071417DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES2Cleared 510(K)
- K071107GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON2Cleared 510(K)
- K070883DURACON X3 CS TIBIAL INSERT2Cleared 510(K)
- K063128ADVANCE SPIKED POROUS TIBIAL BASE2Cleared 510(K)
- K070214GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM2Cleared 510(K)
- K063731ADVANCE STATURE FEMORAL COMPONENT2Cleared 510(K)
- K062654DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS2Cleared 510(K)
- K061433VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE2Cleared 510(K)
- K061223ADVANCE TOTAL KNEE SYSTEM2Cleared 510(K)
- K053505REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS2Cleared 510(K)
- K061521TRIATHLON METAL BACKED PATELLA2Cleared 510(K)
- K060303VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS2Cleared 510(K)
- K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM2Cleared 510(K)
- K053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS2Cleared 510(K)
- K051380TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM2Cleared 510(K)
- K050222VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS2Cleared 510(K)
- K043083ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL2Cleared 510(K)
- K043374DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING2Cleared 510(K)
- K040487TRABECULAR METAL KNEE SYSTEM AUGMENTS2Cleared 510(K)
- K041100NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS2Cleared 510(K)
- K041872ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS2Cleared 510(K)
- K0329053DKNEE POROUS COATED FEMORAL COMPONENT2Cleared 510(K)
- K033489AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN2Cleared 510(K)
- K033971SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING2Cleared 510(K)
- K033972SCORPIO TOTAL KNEE SYSTEM2Cleared 510(K)
- K032108SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)2Cleared 510(K)
- K032683GENESIS II POROUS PLUS HA KNEE SYSTEM2Cleared 510(K)
- K031061NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS2Cleared 510(K)
- K032163DURACON TOTAL KNEE SYSTEM2Cleared 510(K)
- K032418DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING2Cleared 510(K)
- K031462THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS2Cleared 510(K)
- K030612GENESIS II TOTAL KNEE SYSTEM2Cleared 510(K)
- K030623SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM2Cleared 510(K)
- 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
UNIKO PointCloud™ Knee Instruments
- Page Type
- Cleared 510(K)
- 510(k) Number
- K193312
- 510(k) Type
- Traditional
- Applicant
- Unik Orthopedics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/2020
- Days to Decision
- 257 days
- Submission Type
- Summary