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
- 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)
- K113167MTF NEW BONE VOILD FILLER2Cleared 510(K)
- K112857INTERFACE BONE VOID FILLER2Cleared 510(K)
- K111944NB3D BONE VOID FILLER2Cleared 510(K)
- K112773NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K110003MTF NEW BONE VOID FILLER2Cleared 510(K)
- K111838INQU PASTE MIX2Cleared 510(K)
- K103799INQU PASTE MIX PLUS2Cleared 510(K)
- K110925NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT2Cleared 510(K)
- K110976ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM2Cleared 510(K)
- K110561FORTROSS BONE VOID FILLER2Cleared 510(K)
- K110787TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)2Cleared 510(K)
- K110368NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K103795DBX DEMINERALIZED BONE MATRIX PUTTY2Cleared 510(K)
- K103784DBX DEMINERALIZED BONE MATRIX PUTTY2Cleared 510(K)
- K103173VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K102722NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY2Cleared 510(K)
- K103036ALLOFUSE PLUS2Cleared 510(K)
- K102937OSTEOPHIL BETA-TCP2Cleared 510(K)
- K102392MICROFUSE PUTTY AND MICROFUSE ST MIS2Cleared 510(K)
- K092541INTERFACE2Cleared 510(K)
- K102545FM-02 BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K101860NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K100841BONEOPTIMIZER2Cleared 510(K)
- K093342BIOGENNIX RPC2Cleared 510(K)
- K100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION2Cleared 510(K)
- K101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN2Cleared 510(K)
- K091912B-GENIN AND R-GENIN2Cleared 510(K)
- K092608SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX2Cleared 510(K)
- K100361NANOSS BONE VOID FILLER2Cleared 510(K)
- K093343GRAFTY QUICKSET2Cleared 510(K)
- K092046BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY2Cleared 510(K)
- K091688A-GRIX RESORBABLE BONE VOID FILLER2Cleared 510(K)
- K093447CARRIGEN2Cleared 510(K)
- K090401ORTHOSS2Cleared 510(K)
- K091302INTEGRA MOZAIK AND OS MOLDABLE MORSELS2Cleared 510(K)
- K073214DUOWEDGE SYNTHETIC BONE SUBSTITUTE2Cleared 510(K)
- K091031PIONEER SURGICAL NANOSS BVF-E2Cleared 510(K)
- K091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE2Cleared 510(K)
- K090641CURIOS2Cleared 510(K)
- K091218DBX DEMINERALIZED BONE MATRIX PUTTY2Cleared 510(K)
- K090387KAINOS+2Cleared 510(K)
- K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K091321OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY2Cleared 510(K)
- K090871CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-122Cleared 510(K)
- K083270WMT COMPOSITE DBM2Cleared 510(K)
- K083449E-MATRIX GRAFT BONE EXTENDER2Cleared 510(K)
- K082166MASTERGRAFT STRIP2Cleared 510(K)
- K082419REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-12Cleared 510(K)
- K071004OSTEOCRETE BONE VOID FILLER2Cleared 510(K)
- K090731NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD2Cleared 510(K)
- K082793INTERGRO DBM2Cleared 510(K)
- K090310EQUIVABONE2Cleared 510(K)
- K082498GRAFTYS HBS2Cleared 510(K)
- K090242GAMMA-BSM, BETA-BSM2Cleared 510(K)
- K090177INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K082918MASTERGRAFT RESORBABLE CERAMIC GRANULES2Cleared 510(K)
- K083279CALTRIX RESORBABLE BONE VOID FILLER2Cleared 510(K)
- K083232MODIFICATION TO:MICROFUSE BONE VOID FILLER2Cleared 510(K)
- K082672NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K071849ALLOFUSE GEL AND PUTTY2Cleared 510(K)
- K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES2Cleared 510(K)
- K082002PROGENIX PLUS2Cleared 510(K)
- K082381GENEX2Cleared 510(K)
- K083033VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES2Cleared 510(K)
- K082338POLYBONE GRANULE & BLOCK2Cleared 510(K)
- K081717TRICOS A RESORBABLE BONE SUBSTITUTE2Cleared 510(K)
- K082442MODIFICATION TO MICROFUSE BONE VOID FILLER2Cleared 510(K)
- K082073ACTIFUSE FLOW BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K081758HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 2761750152Cleared 510(K)
- K081558PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC2Cleared 510(K)
- K081227PLEXUR M2Cleared 510(K)
- K073341GENEX PUTTY2Cleared 510(K)
- K073316CERAMENT BONE VOID FILLER, MODEL A02102Cleared 510(K)
- K081439VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K080009NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT2Cleared 510(K)
- K080065OSFERION2Cleared 510(K)
- K080511PLEXUR-P2Cleared 510(K)
- K080736ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K062691COMPORUS2Cleared 510(K)
- K072444WELLGRAFT PE I2Cleared 510(K)
- K072170WELLGRAFT PE II2Cleared 510(K)
- K073064GRAFTYS BCP2Cleared 510(K)
- K063157MERRIES K-PHATE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K073405PLEXUR M2Cleared 510(K)
- K071199BONALIVE GRANULES2Cleared 510(K)
- K072238BIOSET XCH2Cleared 510(K)
- K072265PROGENIX DMB PUTTY2Cleared 510(K)
- K071187MICROFUSE BONE VOID FILLER2Cleared 510(K)
- K071876CROSS.BONE2Cleared 510(K)
- K063050CAP PLUS2Cleared 510(K)
- K071813MASTERGRAFT PUTTY2Cleared 510(K)
- K062607POLYGRAFT BGS2Cleared 510(K)
- K071912APACERAM BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K072327CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON2Cleared 510(K)
- K072636A-BSM BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K071046SYNTHES CHRONOS COMPOSITE2Cleared 510(K)
- K072597PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT2Cleared 510(K)
- K070751ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY2Cleared 510(K)
- K070998INION BIORESTORE2Cleared 510(K)
- K072355OSSIFUSE BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K072384MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE2Cleared 510(K)
- K072184VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K071428INQU2Cleared 510(K)
- K070897BONEMEDIK, AND BONEMEDIK-S2Cleared 510(K)
- K071121TRIBONE 802Cleared 510(K)
- K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC2Cleared 510(K)
- K063527MBCP+2Cleared 510(K)
- K070132TRIPORE, MODELS HA, BP90, BP152Cleared 510(K)
- K070794ATLANTIK2Cleared 510(K)
- K071155MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER2Cleared 510(K)
- K062630OSSIPRO BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K071237COPIOS BONE VOID FILLER SPONGE AND PASTE2Cleared 510(K)
- K070864BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER2Cleared 510(K)
- K071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K070437PRO-DENSE BONE VOID FILLER2Cleared 510(K)
- K063346PRO OSTEON 500R2Cleared 510(K)
- K063359INQU2Cleared 510(K)
- K070220OSTEOFIX BONE VOID FILLER2Cleared 510(K)
- K062459ORIGEN DBM WITH BIOACTIVE GLASS2Cleared 510(K)
- K062200COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS2Cleared 510(K)
- K061499OSFERION2Cleared 510(K)
- K063124INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS2Cleared 510(K)
- K053218DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX2Cleared 510(K)
- K062353MOZAIK BONE REGENERATION MATRIX - PUTTY2Cleared 510(K)
- K061462BF+ (PH)2Cleared 510(K)
- K062496OSTEOPORE TCP2Cleared 510(K)
- K062495HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM2Cleared 510(K)
- K061311ALLOGRAN-R2Cleared 510(K)
- K060917KENSEY NASH BONE VOID FILLER2Cleared 510(K)
- K061939MODIFICATION TO ALLOMATRIX CUSTOM2Cleared 510(K)
- K053213BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM2Cleared 510(K)
- K060809OSTEO-LINK BONE VOID FILLER PELLETS2Cleared 510(K)
- K061022BIO 1-KIT BIOSORB FILLED CARTRIDGE2Cleared 510(K)
- K060728NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT2Cleared 510(K)
- K060432NOVABONE POROUS-BONE GRAFT SCAFFOLD2Cleared 510(K)
- K060408NORIAN SRS BONE VOID FILLER2Cleared 510(K)
- K060406NORIAN SRS FAST SET PUTTY2Cleared 510(K)
- K051047COLLOSS E BONE VOID FILLER2Cleared 510(K)
- K053319ALLOMATRIX CUSTOM2Cleared 510(K)
- K051617NOVABONE PUTTY - RESORBABLE BONE VOID FILLER2Cleared 510(K)
- K060061STRYKER INJECTABLE CEMENT2Cleared 510(K)
- K060011MIIG SR2Cleared 510(K)
- K053228THERIGRAFT TCP PUTTY BONE VOID FILLER2Cleared 510(K)
- K052812OSSIMEND (TM) BONE GRAFT MATERIAL2Cleared 510(K)
- K051774MBCP2Cleared 510(K)
- K051603STRYKER INJECTABLE CEMENT2Cleared 510(K)
- K051386MASTERGRAFT PUTTY BONE VOID FILLER2Cleared 510(K)
- K051722TRICOS T2Cleared 510(K)
- K052913IGNITE BONE VOID FILLER KIT2Cleared 510(K)
- K052494NOVABONE-BIOACTIVE SYNTHETIC GRAFT2Cleared 510(K)
- K051914GENEROS 80, GENEROS 602Cleared 510(K)
- K051698MERRIES UNI-OSTEO, MODEL CS30250-CS101022Cleared 510(K)
- K051951CERAMENT BONE VOID FILLER2Cleared 510(K)
- K052098CONNEXUS, .5CC, MODEL 023000-0052Cleared 510(K)
- K051775OSTEOMIMETIC SYNTHETIC BONE MATRIX2Cleared 510(K)
- K051615STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES2Cleared 510(K)
- K051406OSTEOCURE RESORBABLE BEAD KIT2Cleared 510(K)
- K042125AFT2Cleared 510(K)
- K051695MARROW PLUS (M+)2Cleared 510(K)
- K050690CONNEXUS2Cleared 510(K)
- K041177SYNTHACER; SYNTRICER2Cleared 510(K)
- K051123CALLOS IMPACT AND INJECT BONE VOID FILLER2Cleared 510(K)
- K050789FORMAGRAFT COLLAGEN BONE GRAFT MATRIX2Cleared 510(K)
- K043005MODIFICATION TO MBCP2Cleared 510(K)
- K050357CAMCERAM TCP2Cleared 510(K)
- K050666GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES2Cleared 510(K)
- K050490OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER2Cleared 510(K)
- K050416OSSAPLAST ORTHO2Cleared 510(K)
- K040419DYNAGRAFT II2Cleared 510(K)
- K040262DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX2Cleared 510(K)
- K031399INTERGRO DBM2Cleared 510(K)
- K043421OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC2Cleared 510(K)
- K043308MODIFICATION TO: HEALOS BONE GRAFT MATERIAL2Cleared 510(K)
- K043420OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE2Cleared 510(K)
- K050025NANOSS BONE VOID FILLER2Cleared 510(K)
- K043514ALLOGRAN-N-BONE VOID FILLER2Cleared 510(K)
- K043347BF+2Cleared 510(K)
- K043045SYNTHES (USA) CHRONOS2Cleared 510(K)
- K042911CEMENTEK LV2Cleared 510(K)
- K040047POLYGRAFT BGS; BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K042636BIOPLUS2Cleared 510(K)
- K042340KASIOS TCP2Cleared 510(K)
- K042305OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 9032Cleared 510(K)
- K041663ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM2Cleared 510(K)
- K041089OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM2Cleared 510(K)
- K041421NAME BONE VOID FILLER2Cleared 510(K)
- K041613NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K041616BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID2Cleared 510(K)
- K041889TRI-OSTETIC2Cleared 510(K)
- K041493CEMENTEK2Cleared 510(K)
- K033707POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX2Cleared 510(K)
- K040082PORE-SI BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K041168ALLOMATRIX PUTTY2Cleared 510(K)
- K041842NORIAN SRS FAST SET PUTTY2Cleared 510(K)
- K040980ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T2Cleared 510(K)
- K033679COPSIOS BONE VOID FILLER (BVF)2Cleared 510(K)
- K040755EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE2Cleared 510(K)
- K033552JAX-TCP2Cleared 510(K)
- K040381HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -152Cleared 510(K)
- K040600GENEX BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K040454BIOFILL BONE VOID FILLER2Cleared 510(K)
- K033722APAPORE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K040669CERAFORM BONE VOID FILLER2Cleared 510(K)
- K040514EOVIA CALCIUM PHOSPHATE CERAMIC2Cleared 510(K)
- K033611CALCIGEN -NAP BONE VOID FILLER2Cleared 510(K)
- K022828OSTEOSET DBM PELLETS, MODEL 8600-48XX2Cleared 510(K)
- K040216CERASORB M ORTHO2Cleared 510(K)
- K040134THERILINK BONE VOID FILLER2Cleared 510(K)
- K033258BONESAVE BONE VOID FILLER2Cleared 510(K)
- K040405CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY2Cleared 510(K)
- K020895ALLOMATRIX MODEL# 862Cleared 510(K)
- K020078EXACTECH RESORBABLE BONE PASTE2Cleared 510(K)
- K032288VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL2Cleared 510(K)
- K032268MBCP2Cleared 510(K)
- K033138CAP3 BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K031826TRIHA +2Cleared 510(K)
- K032286CALCIGEN PSI BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K032130VITOSS-FILLED CARTRIDGE2Cleared 510(K)
- K031838PROFUSION BONE VOID FILLER KIT2Cleared 510(K)
- K032409VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER2Cleared 510(K)
- K031651MODIFICATION TO CERASORB ORTHO2Cleared 510(K)
- K031435BONESOURCE BVF2Cleared 510(K)
- K031040THERIFIL BONE FILLER2Cleared 510(K)
- K031817CELLPLEX TCP SYNTHETIC CANCELLOUS BONE2Cleared 510(K)
- K031319OSTEO-G BONE VOID FILLER SYSTEM2Cleared 510(K)
- K030288POLYGRAFT BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K030554CALLOS2Cleared 510(K)
- K030131OSSATURA BCP BONE VOID FILLER2Cleared 510(K)
- K023553MASTERGRAFT MATRIX2Cleared 510(K)
- K024336MIIG II BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K030178CALCIGEN PSI BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K010555JAX2Cleared 510(K)
- K030266CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ2Cleared 510(K)
- K023703BI-OSTETIC2Cleared 510(K)
- K021963BIOSORB RESORBABLE VOID FILLER2Cleared 510(K)
- K022622CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P2Cleared 510(K)
- K023862NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER2Cleared 510(K)
- K013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)2Cleared 510(K)
- K022629WMT-TCP BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K021551STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT2Cleared 510(K)
- K011531CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER2Cleared 510(K)
- K021336NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K020986MASTERGRAFT RESORBABLE CERAMIC2Cleared 510(K)
- K013790CALCIGEN-S BONE VOID FILER2Cleared 510(K)
- K013960APATIGHT HA-BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K013966APATIGHT-TCP BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K011726MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER2Cleared 510(K)
- K014156CERASORB ORTHO2Cleared 510(K)
- K014053CONDUIT TCP GRANULES2Cleared 510(K)
- K012506MASTERGRAFT RESORBABLE CERAMIC GRANULES2Cleared 510(K)
- K011897NORIAN SRS BONE VOID FILLER2Cleared 510(K)
- K012751HEALOS BONE GRAFT MATERIAL2Cleared 510(K)
- K011048BSM BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K010532OSTEOSET BVF KIT2Cleared 510(K)
- K000122COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)2Cleared 510(K)
- K011386EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K004003PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS302Cleared 510(K)
- K003954STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT2Cleared 510(K)
- K010557JAX GRANULES BONE VOID FILLER2Cleared 510(K)
- K994337VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER2Cleared 510(K)
- K002362SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)2Cleared 510(K)
- K000515PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,2Cleared 510(K)
- K001724STIMULAN -CALCIUM SULFATE BONE VOID FILTER2Cleared 510(K)
- K001559CALCIUM SULFATE PELLETS2Cleared 510(K)
- K991854OSTEOPLAST, MODEL POP2002Cleared 510(K)
- K990131PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K982663STIMULAN- CALCIUM SULFATE BONE VOID FILLER2Cleared 510(K)
- K980817PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L2Cleared 510(K)
- K973704PROFUSION BONE VOID FILLER2Cleared 510(K)
- K963562WRIGHT PLASTER OF PARIS PELLETS2Cleared 510(K)
- K963587WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)2Cleared 510(K)
- K960978WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)2Cleared 510(K)
- 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
CALCIGEN PSI BONE GRAFT SUBSTITUTE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K030178
- 510(k) Type
- Traditional
- Applicant
- Biomet, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/2003
- Days to Decision
- 40 days
- Submission Type
- Summary