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
- 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
- K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute2Cleared 510(K)
- K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™2Cleared 510(K)
- K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)2Cleared 510(K)
- K251556Device 300423 Granules2Cleared 510(K)
- K251720OsteoFlo HydroFiber2Cleared 510(K)
- K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft2Cleared 510(K)
- K243949OsteoFlo HydroFiber2Cleared 510(K)
- K243474MagnetOs MIS2Cleared 510(K)
- K250141Synthecure Synthetic Calcium Sulfate2Cleared 510(K)
- K250521NanoBone® SBX Putty ; NanoBone® QD2Cleared 510(K)
- K250556Porous Biologic Scaffold2Cleared 510(K)
- K250346BonVie+2Cleared 510(K)
- K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCC2Cleared 510(K)
- K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules2Cleared 510(K)
- K242797OsteoFlo HydroFiber2Cleared 510(K)
- K242782GlassBone Granules2Cleared 510(K)
- K241167BioSphere Putty; BioSphere MIS Putty2Cleared 510(K)
- K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )2Cleared 510(K)
- K240765Porous Biologic Scaffold2Cleared 510(K)
- K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty2Cleared 510(K)
- K243506Montage-XT Settable Bone Putty2Cleared 510(K)
- K241802Device 300397 Putty2Cleared 510(K)
- K240450Citrepore™2Cleared 510(K)
- K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™2Cleared 510(K)
- K242299NovaBone Putty - Synthetic Bioactive Bone Graft2Cleared 510(K)
- K242273Cove Putty, OsteoCove Putty2Cleared 510(K)
- K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips2Cleared 510(K)
- K233566Montage-XT Settable, Resorbable Bone Putty2Cleared 510(K)
- K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS2Cleared 510(K)
- K242050Montage Settable Bone Putty2Cleared 510(K)
- K241212MagnetOs Easypack Putty2Cleared 510(K)
- K233259Xerosyn2Cleared 510(K)
- K240621Morpheus® Moldable; Agilon® Moldable2Cleared 510(K)
- K240442MagnetOs Putty2Cleared 510(K)
- K240507NuVasive AttraX Scaffold2Cleared 510(K)
- K240424Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix2Cleared 510(K)
- K240458Synthetic Bone Putty2Cleared 510(K)
- K240459Cerament Bone Void Filler2Cleared 510(K)
- K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)2Cleared 510(K)
- K240453ReBOSSIS2Cleared 510(K)
- K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™2Cleared 510(K)
- K232347MagnetOs Granules2Cleared 510(K)
- K231968Tactoset® Injectable Bone Substitute2Cleared 510(K)
- K230736MagnetOs Putty2Cleared 510(K)
- K233607MagnetOs Easypack Putty2Cleared 510(K)
- K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty2Cleared 510(K)
- K233245MagnetOs Flex Matrix2Cleared 510(K)
- K231716OsteoFlo® HydroPutty™2Cleared 510(K)
- K232668Cove Strip, OsteoCove Strip2Cleared 510(K)
- K232315Catalyst Bone Void Filler2Cleared 510(K)
- K231030Cove Putty, OsteoCove Putty2Cleared 510(K)
- K231270Montage Flowable Settable, Resorbable Bone Paste2Cleared 510(K)
- K231903Montage-QS Settable, Resorbable Bone Putty2Cleared 510(K)
- K230486Cove Strip2Cleared 510(K)
- K231942Mineral Collagen Composite Bioactive Extra Moldable2Cleared 510(K)
- K231714Graftys Quickset2Cleared 510(K)
- K231528Bonalive Orthopedics granules2Cleared 510(K)
- K223915Tactoset2Cleared 510(K)
- K230054DSM Biomedical Calcium Phosphate Cement2Cleared 510(K)
- K222063MONTAGE Settable, Resorbable Bone Putty2Cleared 510(K)
- K220337GaiaBone Bioabsorbable Bone Graft2Cleared 510(K)
- K223563OsteoCNX2Cleared 510(K)
- K221726Uni-FuZe-C Bone Strip2Cleared 510(K)
- K221735Mineral Collagen Composite Bioactive Moldable2Cleared 510(K)
- K221644Synthetic Bone Putty2Cleared 510(K)
- K213803FIBERGRAFT Aeridyan Matrix Bone Graft Substitute2Cleared 510(K)
- K221256Mg OSTEOINJECT2Cleared 510(K)
- K213959MagnetOs Flex Matrix2Cleared 510(K)
- K212721Genex Bone Graft Substitute2Cleared 510(K)
- K212991Osteorevive2Cleared 510(K)
- K213111MagnetOs granules2Cleared 510(K)
- K213342PRO-DENSE LoVisc Bone Graft Substitute2Cleared 510(K)
- K212156ABCcolla Bone Matrix2Cleared 510(K)
- K212135Dry DBM- A Putty2Cleared 510(K)
- K212353DB-EZ Bone Void Filler2Cleared 510(K)
- K211201MagnetOs Easypack Putty2Cleared 510(K)
- K212083Tactoset Injectable Bone Substitute2Cleared 510(K)
- K203218CaP Spheres Pellet Pack2Cleared 510(K)
- K202639si-Mochi2Cleared 510(K)
- K210193DB-Composite2Cleared 510(K)
- K201781Uni-FuZe-P Bone Putty2Cleared 510(K)
- K200507PRO-DENSE LoVisc Bone Graft Substitute2Cleared 510(K)
- K201535Cerament Bone Void Filler2Cleared 510(K)
- K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft2Cleared 510(K)
- K191670CureOs TCP2Cleared 510(K)
- K201464Altapore MIS2Cleared 510(K)
- K193513SIGNAFUSE Bioactive Bone Graft2Cleared 510(K)
- K193075Osteo3 ZP Putty2Cleared 510(K)
- K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)2Cleared 510(K)
- K200640ALTAPORE SHAPE2Cleared 510(K)
- K200752DB-Orthopedics2Cleared 510(K)
- K193487Agilon Strip2Cleared 510(K)
- K193168Agilon Moldable2Cleared 510(K)
- K190956SCS 17-012Cleared 510(K)
- K192363Altapore2Cleared 510(K)
- K193040Resorbable Mesh Device2Cleared 510(K)
- K191974NuVasive AttraX Putty2Cleared 510(K)
- K191513Altapore Shape2Cleared 510(K)
- K191074Sorrento Bone Graft Substitute2Cleared 510(K)
- K190371Morpheus-C2Cleared 510(K)
- K191274BonAlive Granules2Cleared 510(K)
- K191764Inion BioRestore2Cleared 510(K)
- K190754Orthoss(R)2Cleared 510(K)
- K190814AccuFill Bone Substitute Material2Cleared 510(K)
- K190482IGNITE Bone Void Filler2Cleared 510(K)
- K190110NanoBone SBX PUTTY, NanoBone QD2Cleared 510(K)
- K182074Mineral Collagen Composite Bioactive Moldable2Cleared 510(K)
- K190283PROSTIM Injectable Inductive Graft2Cleared 510(K)
- K182670FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute2Cleared 510(K)
- K181958MagnetOs Putty2Cleared 510(K)
- K182823PRODENSE Bone Graft Substitute2Cleared 510(K)
- K180758Osteocera Resorbable Bone Substitute2Cleared 510(K)
- K181721Ceracell Ortho Foam2Cleared 510(K)
- K173933Sorrento Bioglass Bone Graft Substitute2Cleared 510(K)
- K181255PRODENSE Bone Graft Substitute2Cleared 510(K)
- K173424BioSphere Flex2Cleared 510(K)
- K182107CarriGen PF2Cleared 510(K)
- K181225ALTAPORE2Cleared 510(K)
- K181306Actifuse Flow2Cleared 510(K)
- K180853EP Granules™ BVF2Cleared 510(K)
- K181585JGH1 Core Deccompression Procedure Kit2Cleared 510(K)
- K181342JGH1 Bone Graft Substitute2Cleared 510(K)
- K173572DSM Biomedical Calcium Phosphate Cement with Microspheres2Cleared 510(K)
- K180121Rafugen DBM2Cleared 510(K)
- K180080FIBERGRAFT BG Matrix Bone Graft Substitute2Cleared 510(K)
- K173525NovoGro2Cleared 510(K)
- K173362DSM Biomedical Calcium Phosphate Cement2Cleared 510(K)
- K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty2Cleared 510(K)
- K172237Bicera Resorbable Bone Substitute2Cleared 510(K)
- K171629ABCcolla Bone Graft2Cleared 510(K)
- K173301BioSphere MIS Putty (BioSphere MIS)2Cleared 510(K)
- K170165Osteo-P Bone Graft Substitute2Cleared 510(K)
- K173008SCS 17-012Cleared 510(K)
- K172573ReBOSSIS852Cleared 510(K)
- K172497NuVasive AttraX Scaffold2Cleared 510(K)
- K172130Resorbable Mesh Device2Cleared 510(K)
- K170917Bi-Ostetic Bioactive Glass Foam2Cleared 510(K)
- K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)2Cleared 510(K)
- K171563MagnetOs Putty2Cleared 510(K)
- K171284FIBERGRAFT BG Matrix Bone Graft Substitute2Cleared 510(K)
- K170620ReBOSSIS852Cleared 510(K)
- K170306FIBERGRAFT BG Putty Bone Graft Substitute2Cleared 510(K)
- K163621Vitoss Bioactive (BA) Injectable2Cleared 510(K)
- K162087NovoGro2Cleared 510(K)
- K161859MagnetOs2Cleared 510(K)
- K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE2Cleared 510(K)
- K162860MCS Bone Graft2Cleared 510(K)
- K163310NovaBone IRM2Cleared 510(K)
- K160566Cerasorb Ortho Foam2Cleared 510(K)
- K160446MCP Bone Putty2Cleared 510(K)
- K161351NanoBone SBX Putty2Cleared 510(K)
- K161447HydroSet XT2Cleared 510(K)
- K152077MaxiGen2Cleared 510(K)
- K151271BellaFuse2Cleared 510(K)
- K153608Vitoss BiModal Bone Graft Substitute Foam Strip2Cleared 510(K)
- K152589Bio2 CLM BG Bioactive Scaffold2Cleared 510(K)
- K151154FIBERGRAFT BG Morsels2Cleared 510(K)
- K151584AttraX Putty2Cleared 510(K)
- K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)2Cleared 510(K)
- K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)2Cleared 510(K)
- K143692GranOSTM - beta tricalcium phosphate synthetic bone granules2Cleared 510(K)
- K150621OsteoSelect PLUS Demineralized Bone Matrix Putty2Cleared 510(K)
- K151172MASTERGRAFT Contain2Cleared 510(K)
- K141725BONGOLD BONE GRAFT MATERIAL2Cleared 510(K)
- K143533FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K141429SORRENTO BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K132868CARRICELL2Cleared 510(K)
- K140913NUROS BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K141189NANOBONE / GRANULATE2Cleared 510(K)
- K141830STIMULAN KIT, STIMULAN RAPID CURE2Cleared 510(K)
- K142104NANOFUSE DBM2Cleared 510(K)
- K142276MCS Bone Graft2Cleared 510(K)
- K142828osteoSPAN Morpheus2Cleared 510(K)
- K143549Vivorte Trabexus2Cleared 510(K)
- K142463Bio2 CLM BG Bioactive Scaffold2Cleared 510(K)
- K141207NOVABONE BIOACTIVE STRIP2Cleared 510(K)
- K142090REBOSSIS2Cleared 510(K)
- K141600NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT2Cleared 510(K)
- K141824MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP2Cleared 510(K)
- K133678CONFIRM BIOACTIVE2Cleared 510(K)
- K140946NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE2Cleared 510(K)
- K141956FIBERGRAFT BG MORSELS2Cleared 510(K)
- K141746AS20 COMPOSITE GRAFT2Cleared 510(K)
- K132211SKAFFOLD NMX BONE VOID FILLER2Cleared 510(K)
- K141841INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP2Cleared 510(K)
- K140844BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC2Cleared 510(K)
- K132470SOLUM IV BONE VOID FILLER2Cleared 510(K)
- K132377OSTEOSPAN MORPHEUS2Cleared 510(K)
- K140375MASTERGRAFT PUTTY, MASTERGRAFT STRIP2Cleared 510(K)
- K130531ULTRAFUSE2Cleared 510(K)
- K132656PRODENSE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K132805BG MORSELS2Cleared 510(K)
- K132050NB3D BONE VOID FILLER2Cleared 510(K)
- K132071BIOACTIVE BONE GRAFT PUTTY2Cleared 510(K)
- K130977SIGNIFY BIOACTIVE2Cleared 510(K)
- K131673MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT2Cleared 510(K)
- K130392KINEX BIOACTIVE2Cleared 510(K)
- K131133VIVORTE BVF LITE2Cleared 510(K)
- K130953NEOTIS; NEOTIS 502Cleared 510(K)
- K130335MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX2Cleared 510(K)
- K122868BIOSPHERE BIOACTIVE BONE GRAFT PUTTY2Cleared 510(K)
- K113871PRO-DENSE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K120354BETA-TCP GRANULES2Cleared 510(K)
- K121453A-GRIX TE RESORABLE BONE VOID FILLER2Cleared 510(K)
- K123691MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)2Cleared 510(K)
- K121313MTF NEW BONE VOID FILLER2Cleared 510(K)
- K121989OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,2Cleared 510(K)
- K110949BICERA (TM) RESORBABLE BONE SUBSTITUTE2Cleared 510(K)
- K120141KENSEY NASH BONE VOID FILLER XC2Cleared 510(K)
- K120279NANOFUSE DBM2Cleared 510(K)
- K120602APACERAM BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K113791B-GENIN, R-GENIN2Cleared 510(K)
- K111018POLYFUSE - NEUROBONE2Cleared 510(K)
- K112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER2Cleared 510(K)
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- 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
Inion BioRestore
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191764
- 510(k) Type
- Special
- Applicant
- Inion Oy
- Country
- Finland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/31/2019
- Days to Decision
- 30 days
- Submission Type
- Summary