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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
- K242315Resolve Modular Revision Hip Stem2Cleared 510(K)
- K243839Alteon® HA Femoral Stems2Cleared 510(K)
- K243162World Liner2Cleared 510(K)
- K241472Icona Hip Stem2Cleared 510(K)
- K241875TheRay Collared and Collarless Femoral Stem2Cleared 510(K)
- K241690Logical Liner; World Liner; World Knee Patella2Cleared 510(K)
- K233758Trivicta™ Hip Stem2Cleared 510(K)
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional2Cleared 510(K)
- K231178ACTERA™ hip system2Cleared 510(K)
- K220495SignaSure Dual Mobility System2Cleared 510(K)
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem2Cleared 510(K)
- K221104Actera™ hip system2Cleared 510(K)
- K211742SignaSure Dual Mobility System2Cleared 510(K)
- K211505Encore Hip Stem2Cleared 510(K)
- K211703Insignia Hip Stem2Cleared 510(K)
- K210581Actis DuoFix Hip Prosthesis- Collarless2Cleared 510(K)
- K200045MUTARS Cemented Femoral Stems2Cleared 510(K)
- K201278World Hip Stem, World Cup, World Liner2Cleared 510(K)
- K193398Summit DuoFix HA Coating2Cleared 510(K)
- K181778MUTARS Proximal Femur Replacement System2Cleared 510(K)
- K173880Corin TriFit CF Hip Stem2Cleared 510(K)
- K171273LINK® BiMobile(TM) Dual Mobility System2Cleared 510(K)
- K171249Entrada™ hip stem2Cleared 510(K)
- K162303REDAPT Sleeved Monolithic Revision Stems2Cleared 510(K)
- K162732Exactech® Alteon® HA Femoral Stem2Cleared 510(K)
- K153649Exactech® Novation® Element Press-fit Femoral Stem2Cleared 510(K)
- K160011H-Max S stem2Cleared 510(K)
- K161155Origin Coxa Vara Hip Stem2Cleared 510(K)
- K160907DePuy Actis DuoFix Hip Prosthesis2Cleared 510(K)
- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner2Cleared 510(K)
- K153772Corin TriFit TS Hip2Cleared 510(K)
- K150855H-MAX S Femoral Hip System2Cleared 510(K)
- K150862DePuy Actis Duofox Hip Prosthesis2Cleared 510(K)
- K122853NOVEL FIT AND FILL STEM2Cleared 510(K)
- K112091H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS2Cleared 510(K)
- K121627SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM2Cleared 510(K)
- K121563CORIN TRIFIT TS HIP2Cleared 510(K)
- K113039SMITH & NEPHEW RADIOPAQUE TRIAL NECKS2Cleared 510(K)
- K113789MODULAR PROXIMALLY FLUTED HIP STEM2Cleared 510(K)
- K113320NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-122Cleared 510(K)
- K113107MSA HIP SYSTEM2Cleared 510(K)
- K112556ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS2Cleared 510(K)
- K103479NOVEL TAPERED HIP STEM2Cleared 510(K)
- K103497CERAMIC FEMORAL HEAD2Cleared 510(K)
- K102172MSA HIP SYSTEM2Cleared 510(K)
- K102424PREVISION HIP SYSTEM WITH RECON RING2Cleared 510(K)
- K093472TRINITY ACETABULAR SYSTEM2Cleared 510(K)
- K100481SMITH & NEPHEW MDF MODULAR SLEEVE2Cleared 510(K)
- K090982SMITH & NEPHEW HIP SYSTEMS WITH HA2Cleared 510(K)
- K092265VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS2Cleared 510(K)
- K093644RESTORATION ADM SYSTEM X3 ACETABULAR2Cleared 510(K)
- K092406ABG II MODULAR HIP STEM2Cleared 510(K)
- K092561REJUVENATE MODULAR STEM2Cleared 510(K)
- K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM2Cleared 510(K)
- K091161REJUVENATE MONOLITHIC SIZE 4 HIP STEM2Cleared 510(K)
- K083116VERSAFIT CUP DOUBLE MOBILITY SYSTEM2Cleared 510(K)
- K082892REJUVENATE MONOLITHIC HIP SYSTEM2Cleared 510(K)
- K081124MDF REVISION HIP SYSTEM2Cleared 510(K)
- K081044REJUVENATE MODULAR HIP SYSTEM2Cleared 510(K)
- K071916METHA HIP SYSTEM2Cleared 510(K)
- K080584METHA SHORT STEM HIP SYSTEM2Cleared 510(K)
- K080980EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS2Cleared 510(K)
- K072020RESTORATION ADM SYSTEM2Cleared 510(K)
- K071583CERMET III ACETABULAR CUP SYSTEM2Cleared 510(K)
- K060437EXCIA TOTAL HIP SYSTEM WITH U-CAP2Cleared 510(K)
- K053528SHORT CITATION FEMORAL STEM2Cleared 510(K)
- K052426SMITH & NEPHEW MODULAR HIP2Cleared 510(K)
- K043079BICONTACT HIP SYSTEM WITH U-CAP2Cleared 510(K)
- K042127SMITH & NEPHEW MODULAR HIP2Cleared 510(K)
- K041353FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K040680CONTOUR HA COATED RECONSTRUCTION RING2Cleared 510(K)
- K040613EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS2Cleared 510(K)
- K032641MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K032300ACCOLADE-J HIP STEM SERIES2Cleared 510(K)
- K023302ECHELON POROUS PLUS HA HIP STEMS2Cleared 510(K)
- K023102ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM2Cleared 510(K)
- K021403HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM2Cleared 510(K)
- K020615SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS2Cleared 510(K)
- K021108ESOP HA FEMORAL STEM2Cleared 510(K)
- K020963TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM2Cleared 510(K)
- K020572ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM2Cleared 510(K)
- K013676TRIDENT HEMISPHERICAL ACETABULAR SHELLS2Cleared 510(K)
- K002996SYNERGY HA COATED POROUS FEMORAL STEMS2Cleared 510(K)
- K001580GROSS FEMORAL COMPONENT2Cleared 510(K)
- K001448TRIDENT ACETABULAR SHELLS: PS-HA2Cleared 510(K)
- K000262BOHN FEMORAL COMPONENT2Cleared 510(K)
- K994366TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM2Cleared 510(K)
- K000242ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE2Cleared 510(K)
- K992815THE MARGRON HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K993943ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA2Cleared 510(K)
- K993768CITATION TMZF HA STEM2Cleared 510(K)
- K993077HOWMEDICA OSTEONICS RESTORATION HA HIP STEM2Cleared 510(K)
- K992025PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING2Cleared 510(K)
- K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL2Cleared 510(K)
- K980070OSTEONICS HA-COATED DEVICES2Cleared 510(K)
- K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS2Cleared 510(K)
- K990197MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM2Cleared 510(K)
- K983382OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K983870OSTEONICS RESTORATION HA HIP STEMS2Cleared 510(K)
- K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS2Cleared 510(K)
- K980766OSTEONICS ANTEVERTED NECK HA HIP STEMS2Cleared 510(K)
- K964878ESOP S/C FEMORAL STEM2Cleared 510(K)
- K971523DISTALLY FIXED HIP STEM2Cleared 510(K)
- K961732KAR2Cleared 510(K)
- K971422OSTEONICS ACETABULAR WEDGE SYSTEM2Cleared 510(K)
- K970394OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K961388ATLAS III ACETABULAR CUP2Cleared 510(K)
- K970337HA GLOBAL TAPER (GT) TAPERED HIP STEM2Cleared 510(K)
- K963959OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)2Cleared 510(K)
- K954800APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)2Cleared 510(K)
- K955305PCA +15MM MODULAR FEMORAL HEAD2Cleared 510(K)
- K951517OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES2Cleared 510(K)
- K954023OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K951671OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES2Cleared 510(K)
- K951932OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES2Cleared 510(K)
- K951291OSTEONICS RESTORATION MONOLITHIC HIP STEM2Cleared 510(K)
- K941366OSTEONICS OMNIFIT AD-HA HIP STEM SERIES2Cleared 510(K)
- K945844DEPUY CDH PROSTHESIS2Cleared 510(K)
- K946234OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES2Cleared 510(K)
- K944836OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES2Cleared 510(K)
- K945691OSTEONICS(R) THREADED HA ACETABULAR SHELLS2Cleared 510(K)
- K942900OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K943957RESTORATION HA ACETABULAR CUP SERIES2Cleared 510(K)
- K942891SUMMIT TOTAL HIP SYSTEM2Cleared 510(K)
- K932017TECHMEDICA CONTINUUM HIP WITH HA COATING2Cleared 510(K)
- K935696ETEX HA HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K934729UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED2Cleared 510(K)
- K935990F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM2Cleared 510(K)
- K935453CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM2Cleared 510(K)
- K922613CL HIP STEM H/A COATED2Cleared 510(K)
- K922621HA TI-FIT ACETABULAR AND FEMORAL COMPONENT2Cleared 510(K)
- K915655STABILITY FEMORAL PROSTHESIS W/HAP2Cleared 510(K)
- K925607HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE2Cleared 510(K)
- K926299CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING2Cleared 510(K)
- K926134H-220 PRESS-FIT ACETABULAR CUP SYSTEM2Cleared 510(K)
- K920969HYDROXYLAPATITE INFINITY(R)2Cleared 510(K)
- K915190PERFECTA TOTAL HIP SYSTEM, HA COATED2Cleared 510(K)
- K921672INTER-HA HIP PROSTHESIS2Cleared 510(K)
- K915617LSF HA COATED FEMORAL HIP2Cleared 510(K)
- K915350HYDROXYAPATITE INFINITY TROCHANTERIC MODULE2Cleared 510(K)
- K914843KINAMED ATH-HA & ATH-HA LONG TOTAL HIP2Cleared 510(K)
- K912713S-ROM ZT HA PROXIMAL FEMORAL SLEEVE2Cleared 510(K)
- K913916HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT2Cleared 510(K)
- K912370HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)2Cleared 510(K)
- K912369HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)2Cleared 510(K)
- K912922DIMENSION-HA HIP PROSTHESIS2Cleared 510(K)
- K912452HA MCCUTCHEN SLT HIP SYSTEM2Cleared 510(K)
- K912263HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC2Cleared 510(K)
- K912654OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP2Cleared 510(K)
- K911728OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C2Cleared 510(K)
- K912395HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT2Cleared 510(K)
- K911585OMNIFIT II EPF HIP STEM SERIES2Cleared 510(K)
- K910156HYDROXYAPATITE COATED PROFILE(R) HIP STEM2Cleared 510(K)
- K910755PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING2Cleared 510(K)
- K905781APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM2Cleared 510(K)
- K896047THE OMNIFIT EPF HIP JOINT FEMORAL STEM2Cleared 510(K)
- 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
World Hip Stem, World Cup, World Liner
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201278
- 510(k) Type
- Traditional
- Applicant
- Signature Orthopaedics Pty Ltd.
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/2020
- Days to Decision
- 131 days
- Submission Type
- Summary