Anesthesiology
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- 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
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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
- K193549SIGMA High Performance (HP) Partial Knee System2Cleared 510(K)
- K190633NanoOrtho NanoKnee® System2Cleared 510(K)
- K152631MPO Total Knee Systems MR Labeling2Cleared 510(K)
- K150410RESTORIS POROUS PARTIAL KNEE SYSTEM2Cleared 510(K)
- K133940OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2Cleared 510(K)
- K131167UNIVATION2Cleared 510(K)
- K122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K110415SIGNATURE PLANNER / SIGNATURE GUIDES2Cleared 510(K)
- K100973EVOLUTION UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K082567STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION2Cleared 510(K)
- K081293UNIVATION UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K072704UNICOMPARTMENTAL KNEE2Cleared 510(K)
- K071881TRIATHLON PKR SYSTEM2Cleared 510(K)
- K070267DEPUY GCK TIBIAL COMPONENTS2Cleared 510(K)
- K063515TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE2Cleared 510(K)
- K061681REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT2Cleared 510(K)
- K060412ACTIVE UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K053299REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT2Cleared 510(K)
- K051721GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K050764UNIGLIDE UNICONDYLAR KNEE PROSTHESIS2Cleared 510(K)
- K042093VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS2Cleared 510(K)
- K040889EXACTECH OPTETRAK UNICONDYLAR KNEE2Cleared 510(K)
- K040268DEPUY PRESERVATION UNICONDYLAR TIBIA2Cleared 510(K)
- K033351GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE2Cleared 510(K)
- K033810NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K032052UC-PLUS SOLUTION UNICONDYLAR KNEE2Cleared 510(K)
- K030446REPICCI LOCKED KEEL TIBIAL BEARING2Cleared 510(K)
- K030193ADVANCE LESS CONFORMING TIBIAL COMPONENT2Cleared 510(K)
- K022437UNI KNEE2Cleared 510(K)
- K021621FIXED BEARING UNI COMPONENT2Cleared 510(K)
- K020741UNICONDYLAR KNEE2Cleared 510(K)
- K012800SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K014171ADVANCE UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K020264REPICCI II UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K012762MJS POSTERIOR STABILIZED KNEE SYSTEM2Cleared 510(K)
- K012591ADVANCE UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K011138OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT2Cleared 510(K)
- K011795WORLAND UNICONDYLAR TIBIAL BEARING2Cleared 510(K)
- K011509BARRETT UNICONDYLAR TIBIAL BEARING2Cleared 510(K)
- K010810DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS2Cleared 510(K)
- K001451MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS2Cleared 510(K)
- K983657OSTEONICS SERIES 7000 AD TIBIAL TRAY2Cleared 510(K)
- K000172DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS2Cleared 510(K)
- K982859UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS2Cleared 510(K)
- K974434OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS2Cleared 510(K)
- K971938REPICCI II UNICONDYLAR KNEE2Cleared 510(K)
- K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM2Cleared 510(K)
- K961900TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM2Cleared 510(K)
- K960617ADVANCE TIBIAL COMPONENT2Cleared 510(K)
- K955778NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM2Cleared 510(K)
- K944538GAS PLASMA STERILIZATION2Cleared 510(K)
- K940389S.T.E.P. UNI-KNEE2Cleared 510(K)
- K933935CKS POROUS COATED FEMORAL COMPONENT2Cleared 510(K)
- K923011OSTEONICS UNIX UNICOMPARTMENTAL2Cleared 510(K)
- P840049P.C.A.(TM) TOTAL KNEE SYSTEM2PMA Approval
- K910968P.F.C. UNICONDYLAR KNEE SYSTEM2Cleared 510(K)
- K911373OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP2Cleared 510(K)
- K902538WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION2Cleared 510(K)
- K890044BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE2Cleared 510(K)
- K883969UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM2Cleared 510(K)
- K884837KINEMAX TIBIAL WEDGE2Cleared 510(K)
- P840049P.C.A.(TM) TOTAL KNEE SYSTEM2PMA Approval
- K882241KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM2Cleared 510(K)
- K873601AGC UNICOMPARTMENTAL KNEE PROSTHESIS2Cleared 510(K)
- K864070WHITESIDE ORTHOLOC (TM)2Cleared 510(K)
- K862125ARIZONA CONDYLAR TIBIAL PLATEAU2Cleared 510(K)
- K860133MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU2Cleared 510(K)
- K842367HOWMEDICA KINEMATIC II TIBIAL WEDGE2Cleared 510(K)
- K834298UNICONDYLAR FIBER METAL KNEE2Cleared 510(K)
- K831143P.C.A. UNICOMPARTMENTAL KNEE PROSTHES2Cleared 510(K)
- K821341IOI METAL BACKED TIBIAL COMPONENT2Cleared 510(K)
- K820002BARD CONTOUR LINK S.K.I. KNEE SYS2Cleared 510(K)
- K820030HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE2Cleared 510(K)
- K812012TOWNLEY UNICONDYLAR KNEE2Cleared 510(K)
- K810540KNEE PROSTHESIS2Cleared 510(K)
- K810060P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH2Cleared 510(K)
- K810616MILLER MULTI-RADIUS TOTAL KNEE2Cleared 510(K)
- K810230CONDYLAR KNEE W/METAL ENCAPSULATED TIB2Cleared 510(K)
- K802446RANAWAT ESF TOTAL CONDYLAR KNEE2Cleared 510(K)
- K792619RMC KNEE METAL SHOE TIBIAL COMPONENTS2Cleared 510(K)
- K792325LIVERPOOL KNEE PROSTHESIS2Cleared 510(K)
- K790762PLATFORM TCCK TOTAL KNEE2Cleared 510(K)
- K790348ANAMETRIC TIBIAL COMPONENT METAL TRAY2Cleared 510(K)
- K790350POSTERIOR CRUCIATE CONDYLAR TIBIAL2Cleared 510(K)
- K790349TOTAL CONDYLAR KNEE PROSTHESIS2Cleared 510(K)
- K781608CENTRAL PEG TIBIAL COMPONENT2Cleared 510(K)
- K780299TOTAL KNEE SYSTEM2Cleared 510(K)
- K761278TOTAL TIBIAL KNEE2Cleared 510(K)
- K760842GEOMEDIC ANAMETRIC TOTAL KNEE2Cleared 510(K)
- K760744TAVERNETTI-TENNANT2Cleared 510(K)
- K760334PROSTEHSIS, TOTAL KNEE REPLACEMENT2Cleared 510(K)
- K760245PROSTHESIS, RICHARDS MOD II KNEE2Cleared 510(K)
- 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
- 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
S.T.E.P. UNI-KNEE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K940389
- 510(k) Type
- Traditional
- Applicant
- S.T.E.P. ORTHOPAEDICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 1/19/1995
- Days to Decision
- 358 days
- Submission Type
- Statement