Anesthesiology
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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
- K122778PROFEMUR Z REVISION HIP STEM3Cleared 510(K)
- K121544DYNASTY BIOFOAM SHELL3Cleared 510(K)
- K113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS3Cleared 510(K)
- K113322CONSERVE THIN SHELL3Cleared 510(K)
- K112080PRESERVE HIP STEM3Cleared 510(K)
- K112150PROFEMUR GLADIATOR HA HIP STEM3Cleared 510(K)
- K113019PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER3Cleared 510(K)
- K111910GLADIATOR HIP STEM3Cleared 510(K)
- K110836CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY3Cleared 510(K)
- K110400TAPERLOC COMPLETE MICROPLASTY STEM3Cleared 510(K)
- K111699PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM3Cleared 510(K)
- K111698PROFEMUR(R) E CEMENTLESS HIP STEM3Cleared 510(K)
- K110399GLADIATOR PLASMA CLASSIC HIP STEM3Cleared 510(K)
- K110029CONSERVE BIO FOAM SHELL3Cleared 510(K)
- K103755TAPERLOC COMPLETE, SIZE 5 AND 63Cleared 510(K)
- K102565ANTERIOR APPROACH HIP SURGERY INSTRUMENTS3Cleared 510(K)
- K100469ARCOS INTERLOCKING DISTAL STEMS3Cleared 510(K)
- K101086TAPERLOC COMPLETE3Cleared 510(K)
- K101475COMPRESS ANTI-ROTATION SPINDLES3Cleared 510(K)
- K093235RINGLOC + HYBRID ACETABULAR SYSTEM3Cleared 510(K)
- K092331DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;3Cleared 510(K)
- K091003ZIMMER MMC CUP3Cleared 510(K)
- K091973METASUL TAPER LINERS, METASUL FEMORAL HEADS3Cleared 510(K)
- K090757BIOMET MODULAR FEMORAL REVISION SYSTEM3Cleared 510(K)
- K091423PROFEMUR HIP SYSTEM MODULAR NECKS3Cleared 510(K)
- K083651REVELATION STEM, MODEL 427-21/42-080/1803Cleared 510(K)
- K083642DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS3Cleared 510(K)
- K082924DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER3Cleared 510(K)
- K082585DEPUY ASPHERE M-SPEC HEAD3Cleared 510(K)
- K082446BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS3Cleared 510(K)
- K080991DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM3Cleared 510(K)
- K081090PROFEMUR LX 5/8 COATED HIP STEM3Cleared 510(K)
- K081007ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM3Cleared 510(K)
- K080663PROFEMUR LX REVISION 5/8 COATED HIP STEM3Cleared 510(K)
- K073637PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS3Cleared 510(K)
- K071723ZIMMER POROLOCK MIS STEM3Cleared 510(K)
- K073413DEPUY ASR 300 ACETABULAR CUP SYSTEM3Cleared 510(K)
- K071856ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES3Cleared 510(K)
- K070221FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-383Cleared 510(K)
- K070274ECHO BI-METRIC PRESS-FIT STEMS3Cleared 510(K)
- K062994LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS3Cleared 510(K)
- K070359DEPUY ASR TAPER SLEEVE ADAPTER3Cleared 510(K)
- K063614ALTRA FX HIP SYSTEM3Cleared 510(K)
- K063251ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY3Cleared 510(K)
- K062998COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)3Cleared 510(K)
- K062426DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS3Cleared 510(K)
- K063414MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-383Cleared 510(K)
- K063002ALTRA PRESS-FIT HIP SYSTEM3Cleared 510(K)
- K062995M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT3Cleared 510(K)
- K061221DUPUY S-ROM STD HIP STEM PROSTHESIS3Cleared 510(K)
- K061423M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS3Cleared 510(K)
- K060358PROFEMUR TL HIP STEM3Cleared 510(K)
- K060356CONSERVE PLUS QUADRAFIX ACETABULAR SHELL3Cleared 510(K)
- K053536DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS3Cleared 510(K)
- K052915PROFEMUR XTR HIP STEM3Cleared 510(K)
- K053588PROFEMUR LX HIP STEM3Cleared 510(K)
- K052320ENCORE CLP OFFSET TOTAL HIP SYSTEM3Cleared 510(K)
- K052888POROUS TITANIUM ACETABULAR AUGMENTS3Cleared 510(K)
- K050124POROUS COATED ACETABULAR COMPONENTS3Cleared 510(K)
- K043099LINEAGE HA ACETABULAR SHELLS3Cleared 510(K)
- K043547COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM3Cleared 510(K)
- K040627DEPUY ASR MODULAR ACETABULAR CUP SYSTEM3Cleared 510(K)
- K050251BALANCE HIP SYSTEM3Cleared 510(K)
- K043073PROCOTYL-E ACETABULAR SYSTEM3Cleared 510(K)
- K042530CONSERVE PLUS HA ACETABULAR SHELLS3Cleared 510(K)
- K040354METAL/METAL HIP SYSTEM3Cleared 510(K)
- K033943ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED3Cleared 510(K)
- K042037M2A MAGNUM SYSTEM3Cleared 510(K)
- K033634EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED3Cleared 510(K)
- K041425CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL3Cleared 510(K)
- K031963CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD3Cleared 510(K)
- K023786DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER3Cleared 510(K)
- K021349METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)3Cleared 510(K)
- K011110M2A ACETABULAR SYSTEM3Cleared 510(K)
- K003758ALLOFIT ACETABULAR SYSTEM3Cleared 510(K)
- K003250FMP METAL/METAL ACETABULAR INSERT3Cleared 510(K)
- K003523DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS3Cleared 510(K)
- K002883PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS3Cleared 510(K)
- K002379M2A 28MM RINGLOC LINER3Cleared 510(K)
- K001523ULTIMA METAL-ON-METAL ACETABULAR CUP3Cleared 510(K)
- K001536INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS3Cleared 510(K)
- K993438METAL ON METAL ACETABULAR SYSTEM3Cleared 510(K)
- K993569APR METASUL ACETABULAR INSERT3Cleared 510(K)
- K974728INTER-OP METASUL ACETABULAR SYSTEM3Cleared 510(K)
- K922868THOMPSON TYPE HIP PROTHESIS3Cleared 510(K)
- K902111MODIFIED FREEMAN REVISION ACETABULAR CUP3Cleared 510(K)
- K902110MODIFIED FREEMAN ACETABULAR CUP3Cleared 510(K)
- K901626H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED3Cleared 510(K)
- K895157S.A.F. ACETABULAR CUP3Cleared 510(K)
- K885049RS-CUP ACETABULAR PROSTHESIS3Cleared 510(K)
- K882671SAMUELSON SCREWLOC CUP3Cleared 510(K)
- K882675ATH METAL:UHMWPE TOTAL HIP SYSTEM3Cleared 510(K)
- K872768OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.3Cleared 510(K)
- K872985SAMUELSON ACETABULAR CUP3Cleared 510(K)
- K870924CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.3Cleared 510(K)
- K870923SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.3Cleared 510(K)
- K871453ZWEYMUELLER-SL HIP PROSTHESIS STEM3Cleared 510(K)
- K871956MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT3Cleared 510(K)
- K864515RING UPM TOTAL HIP REPLACEMENT3Cleared 510(K)
- K861723(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT3Cleared 510(K)
- K852699FREEMAN ACETABULAR CUP3Cleared 510(K)
- K852351KIRSCHNER SELF-TAPPING ACETABULAR CUP3Cleared 510(K)
- K850840HOWMEDICA THREADED ACETABULAR COMPONENT3Cleared 510(K)
- K851404OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES3Cleared 510(K)
- K843950LINK CEMENTLESS SCREW-IN ACETABULAR CUP3Cleared 510(K)
- K843940LINK CEMENTLESS SCREW-IN ACETABULAR CUP3Cleared 510(K)
- K851213ZWEYMULLER CUP3Cleared 510(K)
- K850773PM CEMENTLESS SCREW-IN ACETABULAR CUP3Cleared 510(K)
- K850766ZIMMER THREADED ACETABULAR CUP3Cleared 510(K)
- K850055PROFILE FEMORAL HIP3Cleared 510(K)
- K844943WEILL CEMENTLESS THREADED ACETABULAR CUP3Cleared 510(K)
- K842518UNILOC-CEMENTLESS & SELF TAP ACETABULAR3Cleared 510(K)
- K842466TITANIUM MITTELMEIER TYPE ACETABULAR3Cleared 510(K)
- K780330TOTAL HIP, LORD MADREPORIC3Cleared 510(K)
- 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
REVELATION STEM, MODEL 427-21/42-080/180
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K083651
- 510(k) Type
- Special
- Applicant
- ENCORE MEDICAL, L.P.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/13/2009
- Days to Decision
- 94 days
- Submission Type
- Summary