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
- K143278LnK Posterior Cervical Fixation System2Cleared 510(K)
- K150753OASYS System2Cleared 510(K)
- K150851Sure Lok Mini Posterior Cervical/Upper Thoracic System2Cleared 510(K)
- K142867Reliance Posterior Cervical-Thoracic System2Cleared 510(K)
- K150254Streamline OCT Occipito-Cervico-Thoracic System2Cleared 510(K)
- K142253SOLSTICE OCT System2Cleared 510(K)
- K150229SOLSTICE OCT System2Cleared 510(K)
- K143249SOLSTICE OCT System2Cleared 510(K)
- K142741OASYS System2Cleared 510(K)
- K142558Caspian OCT/MESA Mini/DENALI Mini Spinal System2Cleared 510(K)
- K140734NEXTGEN ALTIUS OCT SYSTEM2Cleared 510(K)
- K142460EXPEDIUM Spine System/Synapse System2Cleared 510(K)
- K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM2Cleared 510(K)
- K141284CASPIAN SPINAL SYSTEM2Cleared 510(K)
- K133288CASPIAN OCT SPINAL SYSTEM2Cleared 510(K)
- K133556VIRAGE OCT SPINAL FIXATION SYSTEM2Cleared 510(K)
- K140645GIBRALT ROD-TO-ROD CROSS CONNECTORS2Cleared 510(K)
- K133374STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM2Cleared 510(K)
- K133214BLACKBIRD SPINAL SYSTEM2Cleared 510(K)
- K131833CENTURION POCT SYSTEM2Cleared 510(K)
- K132122KESTREL POSTERIOR CERVICAL SPINE SYSTEM2Cleared 510(K)
- K133698SYNAPSE SYSTEM2Cleared 510(K)
- K133094CERTEX OCT SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K131427LOTUS2Cleared 510(K)
- K132332MOUNTAINEER OCT SPINAL SYSTEM2Cleared 510(K)
- K131156LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K121979PASS OCT SPINAL SYSTEM2Cleared 510(K)
- K123783ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS2Cleared 510(K)
- K123656VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K121877GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES2Cleared 510(K)
- K123232SPINEOLOGY SPINOUS PROCESS PLATE2Cleared 510(K)
- K123093STABILINK MIS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K123568VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATE2Cleared 510(K)
- K121725PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM2Cleared 510(K)
- K122292RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM2Cleared 510(K)
- K120998SOLSTICE CROSS CONNECTOR2Cleared 510(K)
- K122378NEXTGEN ALTIUS OCT SYSTEM2Cleared 510(K)
- K121136RENOIR POSTERIOR CERVIAL FIXATION SYSTEM2Cleared 510(K)
- K121808CASIAN, 3.5/4.5 CONNECTORS2Cleared 510(K)
- K121115M.U.S.T PEDICLE SCREW SYSTEM2Cleared 510(K)
- K121191VERTEX RCCONSTRUCTION SYSTEM2Cleared 510(K)
- K113593NEXTGEN ALTIUS OCT SYSTEM2Cleared 510(K)
- K113324REXIOUS HOOK FIXATION SYSTEMS2Cleared 510(K)
- K112757PIONEER POSTERIOR CERVICO THORACIC SYSTEM2Cleared 510(K)
- K113346NEON SYSTEM2Cleared 510(K)
- K112595COFLEX-F2Cleared 510(K)
- K111719OASYS SPINAL SYSTEM2Cleared 510(K)
- K113654CASPIAN2Cleared 510(K)
- K112592AXLE PEEK INTERSPINOUS FUSION SYSTEM2Cleared 510(K)
- K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM2Cleared 510(K)
- K103205BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM2Cleared 510(K)
- K111183ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)2Cleared 510(K)
- K110963ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM2Cleared 510(K)
- K103091LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K110353MOUNTAINEER OCT SPINAL SYSTEM2Cleared 510(K)
- K110522VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K110367PIONEER SPINAL PROCESS FUSION PLATE2Cleared 510(K)
- K102886CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K102195SP-FIX SPINOUS PROCESS FIXATION PLATE2Cleared 510(K)
- K103232CASPIAN SPINAL SYSTEM2Cleared 510(K)
- K101471AXLE INTERSPINOUS FUSION SYSTEM2Cleared 510(K)
- K100888MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K101183MODIFICATION TO: OASYS SYSTEM2Cleared 510(K)
- K101112RELIANCE SPINAL SCREW SYSTEM2Cleared 510(K)
- K101525PIONEER SPINOUS PROCESS FUSION PLATE2Cleared 510(K)
- K093438PARADIGM INTERSPINOUS FUSION PLATE2Cleared 510(K)
- K101084CASPIAN SPINAL SYSTEM2Cleared 510(K)
- K102020VEGA SPAN SPINOUS PROCESS PLATE SYSTEM2Cleared 510(K)
- K100354PRIMAL OK INTERSPINOUS FUSION SYSTEM2Cleared 510(K)
- K093319NUVASIVE VUEPOINT OCT SYSTEM2Cleared 510(K)
- K100685ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K100191LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)2Cleared 510(K)
- K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER2Cleared 510(K)
- K092295PIONEER POSTERIOR CERVICO-THORACIC SYSTEM2Cleared 510(K)
- K093534MODIFICATION TO CASPIAN SPINAL SYSTEM2Cleared 510(K)
- K092656LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K091359GSO PCT SPINAL SYSTEM2Cleared 510(K)
- K090343SENTINEL SPINAL SYSTEM2Cleared 510(K)
- K091365VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM2Cleared 510(K)
- K090565ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM2Cleared 510(K)
- K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIES2Cleared 510(K)
- K090549SYNTHES SYNAPSE TRANSCONNECTOR2Cleared 510(K)
- K090714VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K090252MODIFICATION TO: LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K082728VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K082769MESA AND RANGE SPINAL SYSTEMS2Cleared 510(K)
- K083071VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K081906PROTEX CT CERVICOTHORACIC SPINAL SYSTEM2Cleared 510(K)
- K081107CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS2Cleared 510(K)
- K081297VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K080790MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM2Cleared 510(K)
- K080805MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K072729SIERRA2Cleared 510(K)
- K080526SIERRA SYSTEM2Cleared 510(K)
- K073278SPINOUS PROCESS PLATE SYSTEM2Cleared 510(K)
- K080394BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM2Cleared 510(K)
- K073420BLACKSTONE ASCENT MULTIAXIAL SCREWS2Cleared 510(K)
- K073654BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR2Cleared 510(K)
- K072866ISSYS LP SPINAL FIXATION SYSTEM2Cleared 510(K)
- K071942MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K072081ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM2Cleared 510(K)
- K062447TRAVERSE OCT SPINAL FIXATION SYSTEM2Cleared 510(K)
- K072568MODIFICATION TO OASYS SYSTEM2Cleared 510(K)
- K070742MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K071633LANX DEFORMITY SYSTEM2Cleared 510(K)
- K070341LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K071377POLARIS BE RODS2Cleared 510(K)
- K070966GSO GS1 SPINAL SYSTEM2Cleared 510(K)
- K070638THEKEN ATOLL CERVICO-THORACIC SYSTEM2Cleared 510(K)
- K061943ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM2Cleared 510(K)
- K070300EXPEDIUM SFX CROSS CONNECTOR SYSTEM2Cleared 510(K)
- K062181C-JAWS CERVICAL COMPRESSIVE MINI FRAME2Cleared 510(K)
- K062785LTD POLYAXIAL FIXATION SYSTEM2Cleared 510(K)
- K062513APEX SPINE SYSTEM2Cleared 510(K)
- K061591MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K053418SYNTHES OC FUSION SYSTEM2Cleared 510(K)
- K061579MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K052404DENALI DEFORMITY SYSTEM2Cleared 510(K)
- K060683ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM2Cleared 510(K)
- K060513SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X2Cleared 510(K)
- K060081BASIS SPINAL SYSTEM2Cleared 510(K)
- K052201SOLANAS POSTERIOR STABILIZATION SYSTEM2Cleared 510(K)
- K052734MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052131EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS2Cleared 510(K)
- K052402VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052376MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052123SYNTHES PANGEA SYSTEM2Cleared 510(K)
- K052247NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX2Cleared 510(K)
- K052181MODIFICATION TO XIA SPINAL SYSTEM2Cleared 510(K)
- K051716VERTEBRON PSS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K052180MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K051973MODIFICATION TO: XIA STAINLESS STEEL SYSTEM2Cleared 510(K)
- K052069PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES2Cleared 510(K)
- K051942MALIBU SPINAL SYSTEM2Cleared 510(K)
- K050391PROTEX CT CERVICOTHORACIC SPINAL SYSTEM2Cleared 510(K)
- K050830ZODIAC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K050809CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K050484BASIS SPINAL SYSTEM2Cleared 510(K)
- K043053MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K050189TECHTONIX SYSTEM2Cleared 510(K)
- K050079CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K043522ISSYS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K043473MODIFICATION TO XIA SPINAL SYSTEM2Cleared 510(K)
- K042635DENALI SPINE SYSTEM2Cleared 510(K)
- K043020GLAXY 3.2 SPINAL SYSTEM2Cleared 510(K)
- K043229MODIFICATION TO ALTIUS OCT SYSTEM2Cleared 510(K)
- K042789VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K043355SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X2Cleared 510(K)
- K042673ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K042524MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K042508SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM2Cleared 510(K)
- K042498VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K042143EXCELLA-M SPINAL SYSTEM2Cleared 510(K)
- K042402MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K041808ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM2Cleared 510(K)
- K041925ST360 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K041592CORAL SPINAL SYSTEM2Cleared 510(K)
- K041862CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K041119EXPEDIUM SPINE SYSTEM2Cleared 510(K)
- K041449SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT2Cleared 510(K)
- K040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM2Cleared 510(K)
- K041282MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K033961ALTIUS OCT SYSTEM2Cleared 510(K)
- K033090ICON POLYAXIAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K033980BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)2Cleared 510(K)
- K032094PASSMED SPINAL SYSTEM2Cleared 510(K)
- K031175CLICK'X MONOAXIAL SCREWS AND HOOKS2Cleared 510(K)
- K031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL012Cleared 510(K)
- K031772TI FENESTRATED PLATE2Cleared 510(K)
- K023884MODIFICATION ORIA SPINAL SYSTEM2Cleared 510(K)
- K031893XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM2Cleared 510(K)
- K031595U & I AMERICA SPINAL HOOK SYSTEM2Cleared 510(K)
- K030875MODIFICATION TO COLORADO 2 SPINAL SYSTEM2Cleared 510(K)
- K031452ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO032Cleared 510(K)
- K031533VANTAGE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K030197BLACKSTONE POSTERIOR CERVICAL SYSTEM2Cleared 510(K)
- K030816MSD CABLE REDUCTION SYSTEM2Cleared 510(K)
- K031090MODIFICATION TO XIA STAINLESS STEEL SYSTEM2Cleared 510(K)
- K030252ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)2Cleared 510(K)
- K030253ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL062Cleared 510(K)
- K030241MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K023804MOSS MIAMI SPINAL SYSTEM PIN NUT2Cleared 510(K)
- K023797LAURAIN DEWALD ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K023415MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM2Cleared 510(K)
- K014296CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K022048INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM2Cleared 510(K)
- K023675SYNTHES CERVIFIX/ AXON2Cleared 510(K)
- K023555MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K021679ORIA SPINAL CLIP SYSTEM2Cleared 510(K)
- K023498MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K022374CADENCE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K022191MODIFICATION TO TENOR SPINAL SYSTEM2Cleared 510(K)
- K0226235.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)2Cleared 510(K)
- K021507PLUS PIVOT LINK UNIVERSAL SYSTEM2Cleared 510(K)
- K021061MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K022070XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM2Cleared 510(K)
- K022015MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K021170TSRH SPINAL SYSTEM2Cleared 510(K)
- K021919SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO2Cleared 510(K)
- K021825MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM2Cleared 510(K)
- K021009OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM2Cleared 510(K)
- K020709MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K020134SPIRAL RADIUS 90-D RODDING SYSTEM2Cleared 510(K)
- K014090ENDIUS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K020426MSD WIRE SYSTEM2Cleared 510(K)
- K020236MODIFICATION TO PASS SPINAL SYSTEM2Cleared 510(K)
- K013312P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)2Cleared 510(K)
- K020155DYNA-LOK CLASSIC SPINAL SYSTEM2Cleared 510(K)
- K013196ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM2Cleared 510(K)
- K014267BUTTERFLY PLATE FIXATION SYSTEM2Cleared 510(K)
- K013447ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K013442PASS SPINAL SYSTEM2Cleared 510(K)
- K013823XIA SPINAL SYSTEM2Cleared 510(K)
- K012516EBI SPINELINK - II SPINAL FIXATION SYSTEM2Cleared 510(K)
- K013441ISOLA POLYAXIAL WASHER2Cleared 510(K)
- K012173DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM2Cleared 510(K)
- K003780VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K012870XIA STAINLESS STEEL SYSTEM2Cleared 510(K)
- K012871SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 61772Cleared 510(K)
- K011830TRI-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K011969SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K010681SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM2Cleared 510(K)
- K003823SCS DT-02 TRANSVERSE CONNECTOR2Cleared 510(K)
- K011508CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K010181CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION2Cleared 510(K)
- K010632BUTTERFLY PLATE FUNCTION SYSTEM2Cleared 510(K)
- K010515MODIFICATION TO SYNERGY SPINAL SYSTEM2Cleared 510(K)
- K001535ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION2Cleared 510(K)
- K003911TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)2Cleared 510(K)
- K003351PARSFIX CABLE-SCREW SYSTEM2Cleared 510(K)
- K003822ISOLA CLOSED DUAL ROD CONNECTOR2Cleared 510(K)
- K002733SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM2Cleared 510(K)
- K002059AMT SPINAL SYSTEM2Cleared 510(K)
- K002103SIMPLICITY SPINAL SYSTEM2Cleared 510(K)
- K002959MODIFICATION TO ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K002082SPEEDLINK TRANSVERSE CONNECTOR2Cleared 510(K)
- K002505XIA SPINE SYSTEM2Cleared 510(K)
- K002069ASCEND SPINAL FIXATION SYSTEM2Cleared 510(K)
- K002607MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS2Cleared 510(K)
- K002517USS VAS2Cleared 510(K)
- K001653XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY2Cleared 510(K)
- K001470E-Z LINK CROSS CONNECTOR2Cleared 510(K)
- K001372E-Z LINK CROSS CONNECTOR2Cleared 510(K)
- K001080SPINE SYSTEM EVOLUTION2Cleared 510(K)
- K001532DYNA-LOK CLASSIC SPINAL SYSTEM2Cleared 510(K)
- K001105MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS2Cleared 510(K)
- K994187SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K992885VERSALOK LOW BACK FIXATION SYSTEM2Cleared 510(K)
- K993067SILHOUETTE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K991662TITANIUM HARTSHILL SYSTEM2Cleared 510(K)
- K990986CONTOUR SPINAL SYSTEM2Cleared 510(K)
- K991198DYNA-LOK PLUS SPINAL SYSTEM2Cleared 510(K)
- K991089SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K991586SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)2Cleared 510(K)
- K990965SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K990922OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR2Cleared 510(K)
- K984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY2Cleared 510(K)
- K990303EBI OMEGA 21 SYSTEM2Cleared 510(K)
- K990845MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-152Cleared 510(K)
- K990708TITANIUM VERSALOK2Cleared 510(K)
- K981676CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K984377SYNTHES SPINE CERVIFIX SYSTEM2Cleared 510(K)
- K983904ROGOZINSKI SPINAL ROD SYSTEM2Cleared 510(K)
- K983353SCS SPINAL SYSTEM2Cleared 510(K)
- K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM2Cleared 510(K)
- K983583DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS2Cleared 510(K)
- K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM2Cleared 510(K)
- K983282OMI OCCIPITAL CERVICAL LOOP, MODEL A10892Cleared 510(K)
- K983706MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM2Cleared 510(K)
- K983197SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)2Cleared 510(K)
- K982490TENOR SPINAL SYSTEM2Cleared 510(K)
- K982511DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS2Cleared 510(K)
- K982320DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K982494BWM SPINE SYSTEM2Cleared 510(K)
- K982908MODIFICATION TO EBI SPINELINK SYSTEM2Cleared 510(K)
- K982011DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K980288SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K980121AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS2Cleared 510(K)
- K981452OSTEONICS LONG ARM CONTAINMENT RING2Cleared 510(K)
- K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM2Cleared 510(K)
- K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM2Cleared 510(K)
- K974573DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM2Cleared 510(K)
- K973868SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)2Cleared 510(K)
- K964159CD SPINAL SYSTEM2Cleared 510(K)
- K965221RANSFORD CERVICAL FIXATION SYSTEM2Cleared 510(K)
- K971457BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED2Cleared 510(K)
- K971289SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)2Cleared 510(K)
- K965224EMPOWER ANTERIOR DIRECT SCREWS2Cleared 510(K)
- K964254TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K964404BACFIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K964024DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K962628MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K965145DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K962708TITANIUM CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K960444FINN ROD TO ROD CONNECTOR2Cleared 510(K)
- K964275ALPHA POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K962314HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM2Cleared 510(K)
- K961633CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K962984ISOLA PEDIATRIC COMPONENTS2Cleared 510(K)
- K963639ACROMED PEDICLE SCREW2Cleared 510(K)
- K955807COTREL-DUBOUSSET (CD) SPINAL2Cleared 510(K)
- K955365COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM2Cleared 510(K)
- K955864J.B. S. C1-C2 CLAMP2Cleared 510(K)
- K955927BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)2Cleared 510(K)
- K954696ROGOZINSKI THORACOLUMBAR SPINAL ROD2Cleared 510(K)
- K955348TITANIUM MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K951846MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS2Cleared 510(K)
- K955173SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)2Cleared 510(K)
- K951164CD LIBERTY POSTERIOR SPINCAL SYSTEM2Cleared 510(K)
- K954770CENTRA-LINE GRAPPLE, VARIFIX SYSTEM2Cleared 510(K)
- K954645TITANIUM GDLH POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K953599CLAMP ASSEMBLY2Cleared 510(K)
- K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS2Cleared 510(K)
- K942432J.B.S. CERVICAL SPINE SYSTEM2Cleared 510(K)
- K945781WEBB-MORLEY SPINE SYSTEM2Cleared 510(K)
- K945435BRYAN POSTERIOR SPINAL FIXATOR (BPSF)2Cleared 510(K)
- K945022APOFIX CERVICAL SPINE FIXATION2Cleared 510(K)
- K931381AME UNIVERSAL FIXATION SYSTEM2Cleared 510(K)
- K935113J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE2Cleared 510(K)
- K930009STRYKER 2S SPINAL SYSTEM2Cleared 510(K)
- K933881DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM2Cleared 510(K)
- K930657D-C-S SYSTEM2Cleared 510(K)
- K930515ALPHA SPINAL SYSTEM2Cleared 510(K)
- K934582GDLH VARIABLE ANGLE CONNECTOR2Cleared 510(K)
- K934860TI-FRAME2Cleared 510(K)
- K934007SOFAMOR ORFIL SPINE FIXATION SYSTEM2Cleared 510(K)
- K933205TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON2Cleared 510(K)
- K931225LOW PROFILE MID CROSS BRACING2Cleared 510(K)
- K930891SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST2Cleared 510(K)
- K931208LOW PROFILE SLEAVE NUT ASSEMBLY2Cleared 510(K)
- K914548BRYAN SPINAL FIXATER (BSF)2Cleared 510(K)
- K930531AME(R) RIGID FIXATION SYSTEM2Cleared 510(K)
- K930710SENTRY POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K924474SELBY INSTRUMENTATION2Cleared 510(K)
- K921056COTREL - DUBOUSSET SPINE IMPLANTS2Cleared 510(K)
- K921948SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST2Cleared 510(K)
- K921767COMPACT COTREL -- DUBOUSSET SPINE SYSTEM2Cleared 510(K)
- K924142CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT2Cleared 510(K)
- K915672EDWARDS ADJUSTABLE CONNECTORS2Cleared 510(K)
- K924381PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS2Cleared 510(K)
- K925811TSRH CENTRAL POST HOOKS2Cleared 510(K)
- K922672AUGMENT POSTERIOR SPINAL FIXATION SYSTEM2Cleared 510(K)
- K922504ISOLA(R) TANDEM CONNECTOR2Cleared 510(K)
- K921256LUQUE V SPINAL SYSTEM2Cleared 510(K)
- K920546PARAGON POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K921090ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR2Cleared 510(K)
- K920392ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION2Cleared 510(K)
- K922238LEAPLAZA FRAME2Cleared 510(K)
- K922520MODIFIED TSRH CENTRAL POST HOOKS2Cleared 510(K)
- K923339TSRH L CONNECTOR -- MODIFICATION2Cleared 510(K)
- K912837MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS2Cleared 510(K)
- K914306TSRH(TM) LATERAL OFFSET PLATE2Cleared 510(K)
- K914966TSRH CENTRAL POST HOOKS2Cleared 510(K)
- K920102THE SELBY SYSTEM2Cleared 510(K)
- K920116PWB LUMBOSACRAL SPINE SYSTEM2Cleared 510(K)
- K911663CROSSLINK SYSTEM2Cleared 510(K)
- K904243TSRH VARIABLE ANGLE SACRAL SCREW2Cleared 510(K)
- K913561LUQUE SEGMENTAL SPINAL INSTRUMENTATION2Cleared 510(K)
- K914269EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO2Cleared 510(K)
- K904520RAY SACRAL FIXATION SYSTEM2Cleared 510(K)
- K911307CROSSLINK PLATE2Cleared 510(K)
- K911379DANEK SACRAL HOOK, MODIFICATION2Cleared 510(K)
- K911319TSRH OPEN HEAD BONE SCREW2Cleared 510(K)
- K911528ISOLA(TM) SPINE SYSTEM - ILIAC SCREW2Cleared 510(K)
- K911394ISOLA(TM) SPINE SYSTEM--EYE ROD2Cleared 510(K)
- K905826ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR2Cleared 510(K)
- K905184ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK2Cleared 510(K)
- K903376ACROMED SACRAL SCREW2Cleared 510(K)
- K902775KNIGHT SACRAL SCREW2Cleared 510(K)
- K901005TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)2Cleared 510(K)
- K903461TSRH OFFSET AND SIDE-LOADING HOOKS2Cleared 510(K)
- K902397MODULOCK POSTERIOR SPINAL FIXATION2Cleared 510(K)
- K901587TSRH SACRAL L-CONNECTOR2Cleared 510(K)
- K901590DANEK SACRAL HOOK2Cleared 510(K)
- K895978CHIBA SPINAL SYSTEM2Cleared 510(K)
- K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS2Cleared 510(K)
- K896254DANEK PRECISION ROD SET2Cleared 510(K)
- K895296SELBY II INSTRUMENTATION2Cleared 510(K)
- K896740AXIAL AND OFFSET CROSSLINK PLATES2Cleared 510(K)
- K896603HSC UNIT ROD2Cleared 510(K)
- K890192LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET2Cleared 510(K)
- K895413ACROMED DOUBLE SUBLAMINAR WIRE2Cleared 510(K)
- K895441ACROMED BUTTON SPINAL WIRE2Cleared 510(K)
- K895439ACROMED BEADED SUBLAMINAR WIRE2Cleared 510(K)
- K894702STUART CD UNIVERSAL ROD CONNECTOR CLAMPS2Cleared 510(K)
- K894472CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL2Cleared 510(K)
- K884998SELBY INSTRUMENTATION2Cleared 510(K)
- K884690KIRSCHNER SPINAL FIXATOR KMS-12Cleared 510(K)
- K884161ACROMED ILIAC SCREW2Cleared 510(K)
- K884163ACROMED SPINAL ROD AND SPINAL HOOKS2Cleared 510(K)
- K890187THE C-S DISTRACTION ROD ASSEMBLY2Cleared 510(K)
- K883783TSRH SACRAL SPINAL SCREW2Cleared 510(K)
- K884688MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD2Cleared 510(K)
- K884585LEA PLAZA SPINAL FRAME SYSTEM2Cleared 510(K)
- K884263ROGOZINSKI SPINAL SYSTEM2Cleared 510(K)
- K882070LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS2Cleared 510(K)
- K882068COBB SPINAL ELEVATORS2Cleared 510(K)
- K880211TSRH H/M HOOK HOLDER2Cleared 510(K)
- K880212TSRH H/M HOOK HOLDER W/ROD MOVER2Cleared 510(K)
- K875290LUMBAR IMPACTION SET2Cleared 510(K)
- K880214TSRH H/M TORQUE LIMITING WRENCH2Cleared 510(K)
- K880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD2Cleared 510(K)
- K874882ACROMED CROSS ROD CONNECTOR2Cleared 510(K)
- K871870HSC UNIT ROD2Cleared 510(K)
- K870085ANTERIOR SPINAL FIXATION PLATE2Cleared 510(K)
- K870830WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM2Cleared 510(K)
- K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K854524KIRSCHNER SPINAL PRODUCT SYSTEM2Cleared 510(K)
- K854313SONGER TITANIUM SPINE-L-ROD2Cleared 510(K)
- K851935EDWARDS SACRAL SCREW2Cleared 510(K)
- K850039HALIFAX SPINAL CLAMP2Cleared 510(K)
- K843445SACRAL BAR2Cleared 510(K)
- K843687ROD FOR RACHIS SURGERY2Cleared 510(K)
- K840423HARRINGTON-TYPE INSTRU-SCOLIOSIS2Cleared 510(K)
- K820660A HOOK DRIVER2Cleared 510(K)
- K810329DEPUY SEGMENTALSPINAL SYSTEM2Cleared 510(K)
- K810224ARMSTRONG SPINAL APPLIANCE2Cleared 510(K)
- K802462SYNTHES SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K801120DUNN ANTERIOR DISTRACTION SYSTEM2Cleared 510(K)
- K801080EDWARDS ROD SLEEVES2Cleared 510(K)
- K791009SANTA CASA DISTRACTOR2Cleared 510(K)
- K790465KNEE COMPRESSION HOOK SYSTEM2Cleared 510(K)
- K790238TRANSVERSE TRACTION ASSEMBLY2Cleared 510(K)
- K781443HARRINGTON SPINE INSTRUMENTATION2Cleared 510(K)
- K781444OUTRIGGER DISTRACTION UNIT2Cleared 510(K)
- 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
BACFIX SPINAL FIXATION SYSTEM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K964404
- 510(k) Type
- Traditional
- Applicant
- Spinal Concepts, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 3/26/1997
- Days to Decision
- 142 days