Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- 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
- K234028COPAL® exchange G hip spacer; COPAL® G+V2Cleared 510(K)
- K222632UHR Bipolar Implants, Restoration GAP II Implants2Cleared 510(K)
- K192995OsteoRemedies Hip Spacer System2Cleared 510(K)
- K191981REMEDY Acetabular Cup2Cleared 510(K)
- K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement2Cleared 510(K)
- K173967Remedy Acetabular Cup2Cleared 510(K)
- K143184Evolve UniPolar Head2Cleared 510(K)
- K1124702GC HIP/KNEE MODULAR SPACER2Cleared 510(K)
- K101356Spacer-G and Spacer-K2Cleared 510(K)
- K111911CORIN OPTIMOM MODULAR HEAD2Cleared 510(K)
- K062273SPACER-G TEMPORARY HIP PROSTHESIS2Cleared 510(K)
- K071471CORIN ADAPTOR SLEEVE2Cleared 510(K)
- K063791CORIN UNIPOLAR MODULAR HEAD2Cleared 510(K)
- K062408SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD2Cleared 510(K)
- K061243SMITH & NEPHEW MODULAR FEMORAL HEAD2Cleared 510(K)
- K042973SOLITUDE UNIPOLAR HEAD2Cleared 510(K)
- K031841SPACER G TEMPORARY HIP PROSTHESIS2Cleared 510(K)
- K030972FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)2Cleared 510(K)
- K030205CONSENSUS UNIPOLAR HEAD, COCR2Cleared 510(K)
- K014226UNITRAX MODULAR UNIPOLAR SYSTEM2Cleared 510(K)
- K992570UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE2Cleared 510(K)
- K990309PLUS FRACTURE HEAD PROSTHESIS2Cleared 510(K)
- K984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE2Cleared 510(K)
- K984028THE NEW BIO-MOORE ENDO HEADS2Cleared 510(K)
- K981451ARGOMEDICAL BIPOLAR SYSTEM2Cleared 510(K)
- K974807OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM2Cleared 510(K)
- K973614FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES2Cleared 510(K)
- K965198ULTIMA TPS CEMENTED STEM2Cleared 510(K)
- K965156ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES2Cleared 510(K)
- K962646PRIME MODULAR ENDO HEAD2Cleared 510(K)
- K960538OPTEON UNIPOLAR2Cleared 510(K)
- K955385JOHNSON & JOHNSON AUSTIN MOORE STEM2Cleared 510(K)
- K954534OSTEONICS UNIPOLAR ENDO HEAD2Cleared 510(K)
- K954077UNITRAX V40 MODULAR ADAPTOR2Cleared 510(K)
- K943778OSTEONICS RESTORATION CEMENTED HIP STEM SERIES2Cleared 510(K)
- K950563ULTIMA AUGMENTED UHMWPE CUP2Cleared 510(K)
- K951355LINK SADDLE PROTHESIS2Cleared 510(K)
- K931753CORIN THOMPSON PROSTHESIS, MODIFICATION2Cleared 510(K)
- K931752CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION2Cleared 510(K)
- K940190ULTIMA UNIPOLAR MODULAR HEAD2Cleared 510(K)
- K934353ZIRCONIUM ALLOY UNI-POLAR HEAD2Cleared 510(K)
- K924050TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT2Cleared 510(K)
- K926120CONTOUR FEMORAL HIP STEM WITH POROCOAT2Cleared 510(K)
- K924379ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM2Cleared 510(K)
- K922146OSTRONCS HEMI-HIP STEM SERIES2Cleared 510(K)
- K920231OMNIFIT M-HA HIP STEM SERIES2Cleared 510(K)
- K920193OMNIFLEX M-HA HIP STEM SERIES2Cleared 510(K)
- K915868PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT2Cleared 510(K)
- K903877MTS FEMORAL HIP SYSTEM2Cleared 510(K)
- K902365MODULAR UNIPOLAR SYSTEM2Cleared 510(K)
- K905334THOMPSON TYPE HIP PROSTHESIS2Cleared 510(K)
- K905349AUSTIN MOORE TYPE HIP PROTHESIS2Cleared 510(K)
- K904119PROFILE COLLARED HIP PROSTHESIS2Cleared 510(K)
- K903885KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD2Cleared 510(K)
- K903884KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD2Cleared 510(K)
- K903240THOMPSON TYPE HIS PROSTHESIS2Cleared 510(K)
- K903241AUSTIN MOORE TYPE HIP PROSTHESIS2Cleared 510(K)
- K896853PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA2Cleared 510(K)
- K900638P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT2Cleared 510(K)
- K896105EVOLUTION HIP SYSTEM2Cleared 510(K)
- K895886BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM2Cleared 510(K)
- K891482AML(R) COLLARLESS LATERALIZED FEMORAL HIP2Cleared 510(K)
- K884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.2Cleared 510(K)
- K884789NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI2Cleared 510(K)
- K883179HIP FRACTURE STEM SYSTEM2Cleared 510(K)
- K874915ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS2Cleared 510(K)
- K872535BIOPRO FEMORAL HIP COMPONENT2Cleared 510(K)
- K872776PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT2Cleared 510(K)
- K872025POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS2Cleared 510(K)
- K872878TRI-LOCK MODIFIED FEMORAL PROSTHESIS2Cleared 510(K)
- K871656ORTHOMET AUSTIN-MOORE SYSTEM2Cleared 510(K)
- K864085BROOKER BIO-GROOVE FEMORAL COMPONENT2Cleared 510(K)
- K854791BIO-FIT HIP SYSTEM2Cleared 510(K)
- K855228FEMORAL HEMI-HIP PROSTHESES2Cleared 510(K)
- K853662MUELLER CURVED STEM HEMI-PROSTHESIS2Cleared 510(K)
- K852584POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT2Cleared 510(K)
- K844818NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS2Cleared 510(K)
- K852420BTM TOTAL HIP SYSTEM2Cleared 510(K)
- K850928V.E.P. HIP -VARIABLE ENDO-PROSTHESIS2Cleared 510(K)
- K843995TF-II HIP PROSTHESIS2Cleared 510(K)
- K845025AUSTIN-MOORE MODULAR HIP PROSTHESIS2Cleared 510(K)
- K844488MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS2Cleared 510(K)
- K844486MECRON MRC-HEADLESS FEMORAL COMPONENT2Cleared 510(K)
- K844487MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR2Cleared 510(K)
- K842559WHITESIDE ORTHOLOC TOTAL HIP FEMORAL2Cleared 510(K)
- K842465UNILOC2Cleared 510(K)
- K842234NEW JERSEY FEMORAL STEM2Cleared 510(K)
- K841437PENNSYLVANIA HOSPITAL HIP SYS2Cleared 510(K)
- K833599MODIFIED HPS HIP PROSTHESIS2Cleared 510(K)
- K833403BDH UNIPOLAR FEMORAL COMPONENT A22Cleared 510(K)
- K831851STRAIGHT STEM FEMORAL HEAD PROSTHESIS2Cleared 510(K)
- K831420HIP PROSTHESIS -VARIOUS2Cleared 510(K)
- K830307AUFRANC-TURNER ATS TOTAL HIP SYSTEM2Cleared 510(K)
- K823051METAL KNEE & HIP PROSTHESIS2Cleared 510(K)
- K822321IOI 32 TM FEMORAL COMPONENT2Cleared 510(K)
- K822320KAMPNER FEMORAL COMPONENT2Cleared 510(K)
- K820755THE ORIGINAL LEINBACH PLATFORM TOTAL HIP2Cleared 510(K)
- K821343BDH FEMORAL COMPONENT2Cleared 510(K)
- K811416MOORE HIP PROSTHESIS, PMMA COATED2Cleared 510(K)
- K811738COLLARLESS TAPERED STEM HIP PROSTH. DEV2Cleared 510(K)
- K803191PROSTHESIS, HIP FEMORAL COMPONENT METAL2Cleared 510(K)
- K800207UHR UNIVERSAL6HIP REPLACEMENT2Cleared 510(K)
- K7921813M HS 22 FEMORAL COMPONENT2Cleared 510(K)
- 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
ULTIMA TPS CEMENTED STEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K965198
- 510(k) Type
- Traditional
- Applicant
- JOHNSON & JOHNSON INTERNATIONAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/23/1997
- Days to Decision
- 209 days
- Submission Type
- Summary