Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- 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
- K241468Vertiwedge® Intraosseous System2Cleared 510(K)
- K232790KONG®-TL VBR System and KONG® C VBR System2Cleared 510(K)
- K233359DOMINION Expandable Corpectomy System2Cleared 510(K)
- K231134VerteLoc Spinal System2Cleared 510(K)
- K232173Ascend VBR System, Ascend NanoTec VBR System2Cleared 510(K)
- K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)2Cleared 510(K)
- K202637F3D Corpectomy System2Cleared 510(K)
- K200235KONG-TL VBR System, KONG-C VBR System2Cleared 510(K)
- K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System2Cleared 510(K)
- K192117Small VBR™2Cleared 510(K)
- K190349MediExpand TL Expandable VBR System2Cleared 510(K)
- K192214CarboClear VBR System2Cleared 510(K)
- K183054SYNMESH System2Cleared 510(K)
- K190147COLOSSEUM Mesh2Cleared 510(K)
- K183197PYRAMESH™ Implant System2Cleared 510(K)
- K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) System2Cleared 510(K)
- K183510T2 STRATOSPHERE Expandable Corpectomy System2Cleared 510(K)
- K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System2Cleared 510(K)
- K181921Solidity Vertebral Body Replacement2Cleared 510(K)
- K181328T2 STRATOSPHERE™ Expandable Corpectomy System2Cleared 510(K)
- K173982FORTIFY Corpectomy Spacers2Cleared 510(K)
- K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System2Cleared 510(K)
- K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage2Cleared 510(K)
- K172330Blustone Synergy Silica System2Cleared 510(K)
- K173125T2 STRATOSPHERE™ Expandable Corpectomy System2Cleared 510(K)
- K162315FORTIFY Corpectomy Spacers2Cleared 510(K)
- K172323Omnia Medical VBR2Cleared 510(K)
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System2Cleared 510(K)
- K171704CAPRI Corpectomy Cage System2Cleared 510(K)
- K162133VerteFIT Corpectomy Cage System2Cleared 510(K)
- K170055CAPRI Corpectomy Cage System2Cleared 510(K)
- K170271NuVasive(r) Monolith Corpectomy System2Cleared 510(K)
- K152460Rectangular Corpectomy Cage2Cleared 510(K)
- K151538NuVasive PEEK Corpectomy Railed System2Cleared 510(K)
- K151167NuVasive PEEK Corpectomy System2Cleared 510(K)
- K142005SpineFab Vertebral Body Replacement (VBR) System2Cleared 510(K)
- K142205NuVasive X-CORE(R) Expandable VBR System2Cleared 510(K)
- K142996StaXx(R) XD System2Cleared 510(K)
- K143490VERTA Corpectomy Cage2Cleared 510(K)
- K142030STGC-LORDOTIC2Cleared 510(K)
- K142016CAPRI2Cleared 510(K)
- K142150AIS MODULIFT VBR SYSTEM2Cleared 510(K)
- K140563LATERAL VBR SYSTEM2Cleared 510(K)
- K133802AIS MODULIFT VBR SYSTEM2Cleared 510(K)
- K123758TASMIN R2Cleared 510(K)
- K131724PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE2Cleared 510(K)
- K133207STAXX(R) SYSTEM2Cleared 510(K)
- K131888T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE2Cleared 510(K)
- K122622ENDURAMESH2Cleared 510(K)
- K121889STAXX XD SYSTEM2Cleared 510(K)
- K121176STGC2Cleared 510(K)
- K121107FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)2Cleared 510(K)
- K120570CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM2Cleared 510(K)
- K111294SANTORINI SPINAL SYSTEM2Cleared 510(K)
- K112429GIZA(R) VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K111418STAXX(R) XD SYSTEM2Cleared 510(K)
- K103320SYNTHES XRL2Cleared 510(K)
- K110153SFC VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K112756FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS2Cleared 510(K)
- K102315STAXX XDL SYSTEM2Cleared 510(K)
- K101886DSC/ALF SPINAL SYSTEM2Cleared 510(K)
- K111469STAXXSD SYSTEM2Cleared 510(K)
- K110864BIOSPINE VBR SYSTEM2Cleared 510(K)
- K102682STAXX(R) XD SYSTEM2Cleared 510(K)
- K100976T2 XVBR 1.5 SPINAL SYSTEM2Cleared 510(K)
- K101288STAXX XD SYSTEM2Cleared 510(K)
- K093207ENDURAMESH, MODEL 762.XXX2Cleared 510(K)
- K093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET2Cleared 510(K)
- K083186AESCULAP HYDROLIFT VBR SYSTEM2Cleared 510(K)
- K091426CERVICORE CORPECTOMY CAGE2Cleared 510(K)
- K091743SEC VBR2Cleared 510(K)
- K092336C-THRU SPINAL SYSTEM2Cleared 510(K)
- K090841ADDPLUS2Cleared 510(K)
- K091946VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX2Cleared 510(K)
- K091883T2 SPINAL SYSTEM2Cleared 510(K)
- K091406ATLAS SPINE SPACER2Cleared 510(K)
- K090315STAXX XD SYSTEM2Cleared 510(K)
- K090176NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K083857LDR SPINE ROI-C IMPLANT2Cleared 510(K)
- K082466XYCOR SPINAL IMPLANT2Cleared 510(K)
- K082112T2 XVBR SPINAL SYSTEM2Cleared 510(K)
- K081383RELIANCE VBS SYSTEM2Cleared 510(K)
- K080971SPINESMITH CIMPLICITY SPINAL SYSTEM2Cleared 510(K)
- K081564CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION2Cleared 510(K)
- K072326OSTAPEK VBR SYSTEM2Cleared 510(K)
- K081332ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K080860CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K080728LDR SPINE ROI-C IMPLANT2Cleared 510(K)
- K080699NOVEL SPINAL SPACER SYSTEM2Cleared 510(K)
- K080569LDR SPINE ROI-T IMPLANT2Cleared 510(K)
- K080568X-MESH EXPANDABLE CAGE SYSTEM2Cleared 510(K)
- K080572LDR SPINE ROI-A IMPLANT2Cleared 510(K)
- K073502VERTEBRON VBR SYSTEM2Cleared 510(K)
- K080349KIMBA MINI2Cleared 510(K)
- K073649BENGAL STACKABLE CAGE SYSTEM2Cleared 510(K)
- K080024ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-012Cleared 510(K)
- K073505MODIFICATION TO VALEO VBR2Cleared 510(K)
- K072537CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K073125VALEO VBR2Cleared 510(K)
- K071726ZUMA2Cleared 510(K)
- K072029PHENIX VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K072465NIKO CORPECTOMY SPACER2Cleared 510(K)
- K063637RELIANCE VBS SYSTEM2Cleared 510(K)
- K070754TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-1552Cleared 510(K)
- K072132LDR SPINE ROI-T SYSTEM2Cleared 510(K)
- K071274GSO GS1 SPACER2Cleared 510(K)
- K071033T2 XVBR SPINAL SYSTEM2Cleared 510(K)
- K071031VU E*POD VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K071497ATLAS SPINE VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K070786X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K063393SMALL STATURE SPACERS2Cleared 510(K)
- K071372MODIFICATION TO: INTERPLATE VBR SYSTEM2Cleared 510(K)
- K070382VISTA -S DEVICE2Cleared 510(K)
- K070381THEKEN VU MESH VBR SYSTEM2Cleared 510(K)
- K070082XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY2Cleared 510(K)
- K070316INTERPLATE VBR SYSTEM2Cleared 510(K)
- K070181SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX2Cleared 510(K)
- K070218VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)2Cleared 510(K)
- K062083SYNFIX -LR2Cleared 510(K)
- K070173VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K063464ATLAS SPINE VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K063491T2 SCEPTOR SPINAL SYSTEM2Cleared 510(K)
- K063205ATLAS SPINE VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K063399ALEUTIAN SPACER SYSTEM2Cleared 510(K)
- K062933SYNTHES ORACLE SPACER2Cleared 510(K)
- K062666VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS2Cleared 510(K)
- K062759PARAMOUNT VBR SYSTEM2Cleared 510(K)
- K061578SSP VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K060416OBELISC VERTEBRAL BODY REPLACEMENT DEVICE2Cleared 510(K)
- K062151BOX PEEK VBR SYSTEM2Cleared 510(K)
- K061082MOBIS SPINAL IMPLANT2Cleared 510(K)
- K062810SOLITAIRE ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K062133MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K060762AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K062427VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K061891SYNEX II2Cleared 510(K)
- K061401INTERPLATE VBR SYSTEM2Cleared 510(K)
- K062132AVS PL PEEK SPACER SYSTEM2Cleared 510(K)
- K062004MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K061752SPINAL USA VBR SYSTEM2Cleared 510(K)
- K062073VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K061938VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K061836AVS ASL PEEK SPACER SYSTEM2Cleared 510(K)
- K061151PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)2Cleared 510(K)
- K061576MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K061380RETAIN RADIOLUCENT SPACER2Cleared 510(K)
- K061016EBI ESL PEEK-OPTIMA SPINE SYSTEM2Cleared 510(K)
- K060916ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.2Cleared 510(K)
- K060506STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K060665XPAND RADIOLUCENT CORPECTOMY SPACER2Cleared 510(K)
- K052670STAXX XD SYSTEM2Cleared 510(K)
- K060719MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K052641MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K060350CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM2Cleared 510(K)
- K051525ARX SPINAL SYSTEM2Cleared 510(K)
- K053508SYNFIX-LR2Cleared 510(K)
- K053292DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS2Cleared 510(K)
- K052170SEASPINE VBR SYSTEM2Cleared 510(K)
- K051781GRAFTCAGE TLX2Cleared 510(K)
- K052210NUVASIVE COROENT EXTENSURE SYSTEM2Cleared 510(K)
- K053080GRAFTCAGE ACX2Cleared 510(K)
- K052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K052931MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K051205STRYKER SPINE AVS ASL PEEK SPACER2Cleared 510(K)
- K052533KIMBA SPINAL IMPLANT2Cleared 510(K)
- K052746CONCORDE VBR SPINAL SYSTEM2Cleared 510(K)
- K052384LANX VBR SYSTEM2Cleared 510(K)
- K052261MODIFICATION TO: VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K050997EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE2Cleared 510(K)
- K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K052096NUBIC SPINAL IMPLANT2Cleared 510(K)
- K051454ALEUTIAN SPACER SYSTEM2Cleared 510(K)
- K051659SEMIAL SPINAL IMPLANT2Cleared 510(K)
- K050449QUANTUM VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K043479MC+ PARTIAL VBR2Cleared 510(K)
- K051027STALIF TT2Cleared 510(K)
- K043349OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)2Cleared 510(K)
- K051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X12Cleared 510(K)
- K051246CONSTRUX MINI PEEK VBR SYSTEM2Cleared 510(K)
- K051105BASIS VERTEBRAL BODY SPACER2Cleared 510(K)
- K050861PEEK CAS2Cleared 510(K)
- K050348CO VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K050850XPAND CORPECTOMY SPACER2Cleared 510(K)
- K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE2Cleared 510(K)
- K050058THEKEN REVEAL VBR SYSTEM2Cleared 510(K)
- K050553NOVEL VBR SPINAL SYSTEM2Cleared 510(K)
- K050624STRYKER SPINE AVS PL PEEK SPACER2Cleared 510(K)
- K042600STANSION MATRIX2Cleared 510(K)
- K042571STRYKER SPINE AVS TL PEEK SPACER2Cleared 510(K)
- K043405NUVASIVE COROENT SYSTEM2Cleared 510(K)
- K043316RABEA SPINAL IMPLANT2Cleared 510(K)
- K041798ATALIA TITANIUM SURGICAL MESH2Cleared 510(K)
- K043206PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)2Cleared 510(K)
- K043566MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K043561MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K042713FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 52Cleared 510(K)
- K042714FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 42Cleared 510(K)
- K041407TITANIUM MESH IMPLANT2Cleared 510(K)
- K042930SPACEVISION CAGE SYSTEM2Cleared 510(K)
- K042268EBI CAS SPINE SPACER SYSTEM2Cleared 510(K)
- K042201NOVEL VBR SPINAL SYSTEM2Cleared 510(K)
- K041389SYNTHES CONTOURED SYNMESH SPACER2Cleared 510(K)
- K041722MODIFICATION TO VBR SPINAL SYSTEM2Cleared 510(K)
- K041617STALIF TT2Cleared 510(K)
- K040928EXPANDABLE PEEK VBR IMPLANT2Cleared 510(K)
- K041939BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS2Cleared 510(K)
- K041888CURVED PEEK TETRIS SPINAL IMPLANT2Cleared 510(K)
- K041197MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K040731STRYKER SPINE VERTEBRAL SPACER2Cleared 510(K)
- K033926HOURGLASS VERTEBRAL BODY SPACER2Cleared 510(K)
- K041556MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K041452MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K033663SPINAL CONCEPTS INC. CODA2Cleared 510(K)
- K040536MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K040482EBI ESL SPINE SPACER SYSTEM2Cleared 510(K)
- K040168MODIFICATION TO GEO STRUCTURE2Cleared 510(K)
- K033702BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K040284SUSTAIN RADIOLUCENT SPACER2Cleared 510(K)
- K033109ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS2Cleared 510(K)
- K040422MODIFICATION TO VERTE-STACK2Cleared 510(K)
- K032064THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM2Cleared 510(K)
- K040167VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K033517SPINAL CONCEPTS INC. CADENCE AND TRAXIS2Cleared 510(K)
- K032371TITANIUM MESH SYSTEM2Cleared 510(K)
- K033837STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM2Cleared 510(K)
- K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K032476NUVASIVE MESH2Cleared 510(K)
- K032527HEDROCEL VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K032700BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS2Cleared 510(K)
- K031672SPINAL CONCEPTS, INC. INFIX SYSTEM2Cleared 510(K)
- K031780VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K031757PEEK TETRIS SPINAL IMPLANT2Cleared 510(K)
- K031914SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE2Cleared 510(K)
- K031823HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX12Cleared 510(K)
- K031302SUSTAIN SPACER2Cleared 510(K)
- K030744BLACKSTONE SURGICAL TITANIUM MESH2Cleared 510(K)
- K031635DEPUY ACROMED VBR SYSTEM2Cleared 510(K)
- K030735MODIFIED VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K030833DEPUY ACROMED VBR SYSTEM2Cleared 510(K)
- K022793TETRIS SPINAL IMPLANT2Cleared 510(K)
- K030736VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES2Cleared 510(K)
- K030601VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K024364SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)2Cleared 510(K)
- K023319NUVASIVE MASH2Cleared 510(K)
- K024049VERTE-SPAN SPINAL SYSTEM2Cleared 510(K)
- K030249SURGICAL TITANIUM MESH SYSTEM2Cleared 510(K)
- K023835DEVEX MESH SYSTEM2Cleared 510(K)
- K022143INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)2Cleared 510(K)
- K023570MODIFICATION TO VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K022563HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX12Cleared 510(K)
- K021791VERTE-STACK SPINAL SYSTEM2Cleared 510(K)
- K021967HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX22Cleared 510(K)
- K011037VERTEBRAL SPACER2Cleared 510(K)
- K021025MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ2Cleared 510(K)
- K020887EBI AIS SPINE SYSTEM2Cleared 510(K)
- K020152SYNTHES VERTEBRAL SPACER TI2Cleared 510(K)
- K020522MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM2Cleared 510(K)
- K020204TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 81892Cleared 510(K)
- K020048MODIFICATION TO GEO STRUCTURE2Cleared 510(K)
- K010378HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ2Cleared 510(K)
- K014145MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 81312Cleared 510(K)
- K011406SPINAL MESH SYSTEM2Cleared 510(K)
- K013382MODIFICATION TO: STACKABLE CAGE SYSTEM2Cleared 510(K)
- K010989TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 81312Cleared 510(K)
- K010930LIFT VB SPINAL SYSTEM2Cleared 510(K)
- K012254VBR2Cleared 510(K)
- K010530GEO STRUCTURE2Cleared 510(K)
- K003709SURGICAL DYNAMICS MESH CAGE SYSTEM2Cleared 510(K)
- K003836SYNTHES SYNEX SPACER SYSTEM2Cleared 510(K)
- K003043SURGICAL TITANIUM MESH SYSTEM2Cleared 510(K)
- K003275SYNTHES SYNMESH SPACER SYSTEM2Cleared 510(K)
- K003155VERTEBRAL BODY REPLACEMENT2Cleared 510(K)
- K001340STACKABLE CAGE SYSTEM2Cleared 510(K)
- K983667IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE2Cleared 510(K)
- K990148STACKABLE CAGE SYSTEM2Cleared 510(K)
- 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
SYNEX II
- Page Type
- Cleared 510(K)
- 510(k) Number
- K061891
- 510(k) Type
- Traditional
- Applicant
- SYNTHES SPINE CO.LP
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/18/2006
- Days to Decision
- 46 days
- Submission Type
- Summary