Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- OphthalmicReview 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
- 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
- K250760SPECTRUM GV Bone Cement2Cleared 510(K)
- K241674OSTEOPAL® V2Cleared 510(K)
- K231556SPECTRUM® GV Bone Cement2Cleared 510(K)
- K211163Bone Cement Genta, Bone Cement HV, Bone Cement LV2Cleared 510(K)
- K212729Bone Cement-Normal Viscosity2Cleared 510(K)
- K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement2Cleared 510(K)
- K213812PALACOS MV pro2Cleared 510(K)
- K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro2Cleared 510(K)
- K202458BonOs Inject, Pedicle screw kits, Cement pusher2Cleared 510(K)
- K210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta2Cleared 510(K)
- K210120BonOs HV, BonOs MV, BonOs LV2Cleared 510(K)
- K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G2Cleared 510(K)
- K193061G3 40 Radiopaque Bone Cement2Cleared 510(K)
- K193059G1 40 Radiopaque Bone Cement2Cleared 510(K)
- K192394Hi-Fatigue Bone Cement2Cleared 510(K)
- K192379Hi-Fatigue G Bone Cement2Cleared 510(K)
- K190766PALACOS fast R+G2Cleared 510(K)
- K181282G3A 40 Bone Cement2Cleared 510(K)
- K182260PALACOS MV2Cleared 510(K)
- K173494OrthoSteady G Bone Cement2Cleared 510(K)
- K172408Biomet Bone Cement R2Cleared 510(K)
- K170802TRAUMACEM™ V+ Injectable Bone Cement2Cleared 510(K)
- K171540Refobacin Bone Cement R2Cleared 510(K)
- K153737OSTEOPAL plus2Cleared 510(K)
- K150408V-STEADY, V-FAST2Cleared 510(K)
- K150119PALACOS R pro2Cleared 510(K)
- K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System2Cleared 510(K)
- K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta2Cleared 510(K)
- K142157PALACOS R+G PRO2Cleared 510(K)
- K123225BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X602Cleared 510(K)
- K123081BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X402Cleared 510(K)
- K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST2Cleared 510(K)
- K092150COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT2Cleared 510(K)
- K091608COBALT MV BONE CEMENT2Cleared 510(K)
- K081155SMARTSET MV BONE CEMENT2Cleared 510(K)
- K070015COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT2Cleared 510(K)
- K062553SIMPLEX P BONE CEMENT2Cleared 510(K)
- K053198SIMPLEX P SPEEDSET BONE CEMENT2Cleared 510(K)
- K053445SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT2Cleared 510(K)
- K053003DEPUY CMW 1, 2 AND 3 BONE CEMENTS2Cleared 510(K)
- K050085OSTEOPAL V2Cleared 510(K)
- K051496COBALT BONE CEMENT2Cleared 510(K)
- K051532COBALT G HV BONE CEMENT2Cleared 510(K)
- K050854PALACOS LV+G2Cleared 510(K)
- K050855PALAMED G2Cleared 510(K)
- K043403CEMEX SYSTEM GENTA FAST BONE CEMENT2Cleared 510(K)
- K041656MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT2Cleared 510(K)
- K032945SIMPLEX X2Cleared 510(K)
- K031673REFOBACIN -PALACOS G2Cleared 510(K)
- K033596CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT2Cleared 510(K)
- K022688VERSABOND AB BONE CEMENT2Cleared 510(K)
- K033563SMARTSET GHV GENTAMICIN BONE CEMENT2Cleared 510(K)
- K033382SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT2Cleared 510(K)
- K030086PALACOS R BONE CEMENT WITH GENTAMICIN2Cleared 510(K)
- K033509MODIFICATION TO VERSABOND BONE CEMENT2Cleared 510(K)
- K023103DEPUY 1 GENTAMICIN BONE CEMENT2Cleared 510(K)
- K030903OSTEOPAL2Cleared 510(K)
- K030904PALAMED2Cleared 510(K)
- K030902PALACOS R2Cleared 510(K)
- K031430CEMEX SYSTEM FAST2Cleared 510(K)
- K014199SURGICAL SIMPLEX P WITH TOBRAMYCIN2Cleared 510(K)
- K022251PALABOND2Cleared 510(K)
- K023012SMARTSET HV BONE CEMENT2Cleared 510(K)
- K021499CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT2Cleared 510(K)
- K021715CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL2Cleared 510(K)
- K013755CONCERT RADIOPAQUE BONE CEMENT2Cleared 510(K)
- K993836GENERATION 4 BONE CEMENT2Cleared 510(K)
- K010586PALAMED BONE CEMENT2Cleared 510(K)
- K000943CEMEX SYSTEM GUN APPLICATION VERSION2Cleared 510(K)
- K002652SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII2Cleared 510(K)
- N17004SURGICAL SIMPLEX P BONE CEMENT2PMA Approval
- K001160VERSABOND BONE CEMENT2Cleared 510(K)
- P970010NORIAN SRS BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT2PMA Approval
- P970010NORIAN SRS CEMENT2PMA Approval
- P960001DEPUY 3 BONE CEMENT2PMA Approval
- P960001DEPUY 1 AND ENDURANCE BONE CEMENTS2PMA Approval
- P960001DEPUY 3 BONE CEMENT2PMA Approval
- P970010NORIAN SRS CEMENT2PMA Approval
- P960001DEPUY 3 BONE CEMENT2PMA Approval
- N18466ORTHOSET BONE CEMENT2PMA Approval
- P810020OSTEOPAL2PMA Approval
- P960001DEPUY 3 BONE CEMENT2PMA Approval
- P810020PALACOS E-FLOW (OSTEOPAL) BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- P960001ENDURANCE BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- P960001ENDURANCE BONE CEMENT2PMA Approval
- N17755OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N17755OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- P960001ENDURANCE BONE CEMENT2PMA Approval
- P960001DEPUY 1 BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17755ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N17755OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17755OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.2PMA Approval
- N18466CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS2PMA Approval
- N17755OSTEOBOND(TM) COPOLYMER BONE CEMENT2PMA Approval
- N18466CMW ORTHOPEDIC BONE CEMENT2PMA Approval
- N17755ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17755ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT2PMA Approval
- N18466CMW ORTHOPAEDIC BONE CEMENT2PMA Approval
- N17003SURGICAL SIMPLEX(R) P BONE CEMENT2PMA Approval
- N18466PROSFIX(TM) BONE CEMENT2PMA Approval
- N17755ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT2PMA Approval
- N17755ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17003SURGICAL SIMPLEX(R) P BONE CEMENT2PMA Approval
- N17755ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT2PMA Approval
- P810020PALACOS R BONE CEMENT2PMA Approval
- N18466ACRYLOC BONE CEMENT2PMA Approval
- N18466CMW(TM)2 QUICK SETTING BONE CEMENT2PMA Approval
- N18466CMW(TM) RADIOPAQUE BONE CEMENT, HALF PACK2PMA Approval
- N17004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT2PMA Approval
- N17003SURGICAL SIMPLEX(R) P BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- P810020PALACOS R BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- P810020PALACOS R BONE CEMENT2PMA Approval
- N18466CMW BONE CEMENT2PMA Approval
- P810020PALACOS R BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17003SURGICAL SIMPLEX BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX RADIOPAQUE BONE CEMENT2PMA Approval
- N17113OMNIPLASTIC BONE CEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755BONECEMENT2PMA Approval
- N17755ZIMMER(R) BONE CEMENT2PMA Approval
- N17004SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT2PMA Approval
- N17003SURGICAL SIMPLED P BONE CEMENT2PMA Approval
- 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
Hi-Fatigue G Bone Cement
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K192379
- 510(k) Type
- Traditional
- Applicant
- Osartis GmbH
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/27/2019
- Days to Decision
- 89 days
- Submission Type
- Summary