Anesthesiology
Review Panel
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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
- K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)2Cleared 510(K)
- K251436Resolve Anterior Cervical Plate System2Cleared 510(K)
- K250446Frida™ Anterior Cervical Plate System2Cleared 510(K)
- K250602X-PAC® N-GAGE™ Lumbar Plate System2Cleared 510(K)
- K250486Skyway Anterior Cervical Plate System2Cleared 510(K)
- K243904Elegance® Anterior Cervical plate2Cleared 510(K)
- K243369Cervical Plating System2Cleared 510(K)
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI2Cleared 510(K)
- K243015Skyway Anterior Cervical Plate System2Cleared 510(K)
- K231251FlexWing Anterior Cervical Plate System2Cleared 510(K)
- K240592Wolff's Law Anterior Cervical Plate System2Cleared 510(K)
- K241175MiRus MoRe Lumbar Plating System2Cleared 510(K)
- K240935ARENAL Anterior Cervical Plate System2Cleared 510(K)
- K233215icotec Anterior Cervical Plate System2Cleared 510(K)
- K240484MSFX Mikron Cervical Anterior Plate System2Cleared 510(K)
- K232256Alcantara Thoracolumbar Plate System2Cleared 510(K)
- K240423TDM Anterior Cervical Plate System2Cleared 510(K)
- K240690STRUXXURE® MCS Anterior Cervical Plate System2Cleared 510(K)
- K240515uNion® MAX Cervical Plate System2Cleared 510(K)
- K233360Curiteva Thoracolumbar Plate System2Cleared 510(K)
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System2Cleared 510(K)
- K231715MONDRIAN™ Anterior Lumbar Plate System2Cleared 510(K)
- K233735ADIRA™ Lateral Plate System2Cleared 510(K)
- K232318VICTORY™ Lumbar Plate System2Cleared 510(K)
- K231766Skyway Anterior Cervical Plate System2Cleared 510(K)
- K231593Sapphire X3 Anterior Cervical Plate System2Cleared 510(K)
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System2Cleared 510(K)
- K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System2Cleared 510(K)
- K230993CODA™ Anterior Cervical Plate System2Cleared 510(K)
- K231090Zevo Anterior Cervical Plate System2Cleared 510(K)
- K231145Axis Anterior Cervical Plate System2Cleared 510(K)
- K230721ATEC Lateral Plate System2Cleared 510(K)
- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System2Cleared 510(K)
- K223753Cervical Plate System2Cleared 510(K)
- K223321Omnia Medical Coupler-C Anterior Cervical Plate2Cleared 510(K)
- K230301Athena III Cervical Plate System2Cleared 510(K)
- K221053Magnes-C Anterior Cervical Plate System2Cleared 510(K)
- K223627PreView-III™ Anterior Cervical Plate System2Cleared 510(K)
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System2Cleared 510(K)
- K220843OAKTREE Anterior Lumbar Plate and Screw System2Cleared 510(K)
- K222493CODA™ Anterior Cervical Plate System2Cleared 510(K)
- K222628Life Spine ALIF Buttress Plate System2Cleared 510(K)
- K220334MONET Anterior Cervical Plate System2Cleared 510(K)
- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate2Cleared 510(K)
- K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System2Cleared 510(K)
- K220441CYGNUS™ MoRe Anterior Cervical Plate System2Cleared 510(K)
- K221572VyPlate Anterior Cervical Plate System2Cleared 510(K)
- K211718Venus Cervical Plate System2Cleared 510(K)
- K212527Cervical Spine Truss System Plating Solution (CSTS-PS)2Cleared 510(K)
- K220182Aggeris™-C2Cleared 510(K)
- K213820BALTEUM - ONE™ Lumbar Plate System2Cleared 510(K)
- K220275EMERGE Anterior Cervical Plate System2Cleared 510(K)
- K220324AccuFit Lateral 2-Hole Plate2Cleared 510(K)
- K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate System2Cleared 510(K)
- K220147Aspiron S ACP System2Cleared 510(K)
- K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System2Cleared 510(K)
- K213901Cyclops™ Anterior Cervical Plate System2Cleared 510(K)
- K213219Vy Spine™ VyWasher™ Buttress System2Cleared 510(K)
- K213456Xenco Medical Multilevel CerviKit2Cleared 510(K)
- K213443Insignia™ Anterior Cervical Plate System2Cleared 510(K)
- K212937Dakota ALIF Plate System2Cleared 510(K)
- K212446NuVasive Anterior Cervical Plate Systems2Cleared 510(K)
- K210424Quantum Anterior Cervical Plate2Cleared 510(K)
- K212405EMERGE™ Anterior Cervical Plate System2Cleared 510(K)
- K212139Admiral ACP System2Cleared 510(K)
- K211903Shoreline Threaded TruProfile® Plate2Cleared 510(K)
- K211205Prase-C Anterior Cervical Plate System2Cleared 510(K)
- K211932Fixxsure Anterior Lumbar Plate and Screw System2Cleared 510(K)
- K211408CervAlign® Anterior Cervical Plate System2Cleared 510(K)
- K210182PANAMA™ Anterior Cervical Plate (ACP) System2Cleared 510(K)
- K210325APOLLO Anterior Cervical Plate (ACP) System2Cleared 510(K)
- K210286Cure 2.0 Anterior Cervical Plate (ACP) System2Cleared 510(K)
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)2Cleared 510(K)
- K202878Prase-AP Anterior Cervical Plate System2Cleared 510(K)
- K203253NuVasive ACP System2Cleared 510(K)
- K202972Anterior Cervical Plate System2Cleared 510(K)
- K203154KASILOF Cervical Plate System2Cleared 510(K)
- K202624Z-Span Plate System2Cleared 510(K)
- K201587icotec Anterior Cervical Plate System2Cleared 510(K)
- K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System2Cleared 510(K)
- K202192STRUXXURE®-L and STRUXXURE®-A Plate System2Cleared 510(K)
- K202227Artus™ cervical plate system2Cleared 510(K)
- K202064Admiral ACP System2Cleared 510(K)
- K201979Cervical Plate System2Cleared 510(K)
- K201521Medina Anterior Cervical Plate System2Cleared 510(K)
- K201079Aurora® Anterior Lumbar Plate Sytstem2Cleared 510(K)
- K192481AccelFix Lumbar Plate System2Cleared 510(K)
- K200927Transept Cervical Plate System2Cleared 510(K)
- K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System2Cleared 510(K)
- K200883CarboClear® Cervical Plate System2Cleared 510(K)
- K200885Meridian Anterior Plate System, Regatta Lateral Plate System2Cleared 510(K)
- K200995Insignia™ Anterior Cervical Plate System2Cleared 510(K)
- K200956NuVasive Thoracolumbar Plates2Cleared 510(K)
- K201078NuVasive® ACP System2Cleared 510(K)
- K201136Cure™ Lumbar Plate System2Cleared 510(K)
- K200846Balteum™ Lumbar Plate System2Cleared 510(K)
- K200523Biolign® Roto-Loc Cervical Plate System2Cleared 510(K)
- K193494Origin™ Anterior Cervical Plate System2Cleared 510(K)
- K200224SEA-LINK Anterior Cervical Plate System2Cleared 510(K)
- K200170SpineNet SSP System2Cleared 510(K)
- K192792TranS1 AxiaLIF Plus System2Cleared 510(K)
- K192049Oryx Cervical Plate System2Cleared 510(K)
- K192494NexGen Anterior Cervical Plate System2Cleared 510(K)
- K192678Genesys Spine Binary® Lumbar Plate System2Cleared 510(K)
- K192314RESONATE Anterior Cervical Plate System2Cleared 510(K)
- K191584FORTICO Anterior Cervical Fixation System2Cleared 510(K)
- K191500NuVasive® ACP System2Cleared 510(K)
- K191786Cyclops™ Anterior Cervical Plate System2Cleared 510(K)
- K192076Binary® Anterior Cervical Plate System2Cleared 510(K)
- K190016Lateral Plate System2Cleared 510(K)
- K190565Cervical Plate2Cleared 510(K)
- K183084Fuji Cervical Plate System2Cleared 510(K)
- K190584CAYMAN LP Plate System2Cleared 510(K)
- K190170MVP Cervical Plate System2Cleared 510(K)
- K190666CYGNUS™ Anterior Cervical Plate System2Cleared 510(K)
- K190227Boomerang™ Anterior Cervical Plate System2Cleared 510(K)
- K183056ASSURE® Anterior Cervical Plate System2Cleared 510(K)
- K190425CastleLoc-P Anterior Cervical Plate System2Cleared 510(K)
- K183409Athena II Cervical Plate System2Cleared 510(K)
- K183073SMG Anterior Cervical Plate System2Cleared 510(K)
- K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System2Cleared 510(K)
- K190053SECULOK™ ACP System2Cleared 510(K)
- K183060CervAlign™ Anterior Cervical Plate System2Cleared 510(K)
- K181190Pinehurst Anterior Cervical Plate System2Cleared 510(K)
- K1824894CIS® Pinehurst Anterior Cervical Plate system2Cleared 510(K)
- K183214Raven Lumbar Plate System2Cleared 510(K)
- K180772Met One Czar Anterior Cervical Plate System2Cleared 510(K)
- K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems2Cleared 510(K)
- K182418V3 Segmental Plating System2Cleared 510(K)
- K182808Aspida® Anterior Lumbar Plating System2Cleared 510(K)
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System2Cleared 510(K)
- K182055SECULOK™ ACP System2Cleared 510(K)
- K181543Cure™ OPEL-C Plate System2Cleared 510(K)
- K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)2Cleared 510(K)
- K181562Curiteva Anterior Cervical Plate System2Cleared 510(K)
- K180022Athena Cervical Plate System2Cleared 510(K)
- K181063Kestrel™ Buttress Plate System2Cleared 510(K)
- K181244Zavation Cervical Plate System2Cleared 510(K)
- K180755Vail ALIF Buttress Plate System2Cleared 510(K)
- K180166Life Spine Lumbar Fixation System (SENTRY)2Cleared 510(K)
- K180090Cure™ Lumbar Plate System2Cleared 510(K)
- K173935Mediant Anterior Cervical Plating System2Cleared 510(K)
- K173867Axis Anterior Cervical Plate System2Cleared 510(K)
- K173885Genesys Spine Binary Lumbar Plate System2Cleared 510(K)
- K180537Zavation Buttress Plate System2Cleared 510(K)
- K171797TRYPTIK2 C-Plate Anterior Cervical Plate System2Cleared 510(K)
- K173521SeaSpine Cabo ACP (Anterior Cervical Plate) System2Cleared 510(K)
- K173306EZ Plate2Cleared 510(K)
- K173375Anterior Cervical Plate System2Cleared 510(K)
- K173091Boundary Anterior Lumbar Buttress Plate2Cleared 510(K)
- K173099Fortis and Hana Anterior Cervical Plate System2Cleared 510(K)
- K172585Liberty Anterior Cervical Plate2Cleared 510(K)
- K163366Shanghai Sanyou CARMEN Cervical Fusion System2Cleared 510(K)
- K172086Matira™ Anterior Cervical System2Cleared 510(K)
- K1721312 Hole Lateral Plating System2Cleared 510(K)
- K172104Ozark(tm) Cervical Plate System2Cleared 510(K)
- K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System2Cleared 510(K)
- K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System2Cleared 510(K)
- K170224Spider Cervical Plating System2Cleared 510(K)
- K163104Terrace™ Anterior Cervical Plate System2Cleared 510(K)
- K171538Cure™ Lumbar Plate System2Cleared 510(K)
- K171112Trifore(tm) Cervical Plating System2Cleared 510(K)
- K170342Ocata Anterior Cervical System2Cleared 510(K)
- K170530Butrex Lumbar Buttress Plating System2Cleared 510(K)
- K162824Z-Span Plate System2Cleared 510(K)
- K163602Kepler I Cervical Plate System2Cleared 510(K)
- K163061Altus Spine Cervical Plate System2Cleared 510(K)
- K161641LOSPA IS ACP System2Cleared 510(K)
- K160982Sphynx™2Cleared 510(K)
- K162638CETRA Anterior Cervical Plate System2Cleared 510(K)
- K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System2Cleared 510(K)
- K162211AccuFit Lateral Plate System2Cleared 510(K)
- K162250FortiBridge Anterior Cervical Plate System2Cleared 510(K)
- K162664Pyrenees Cervical Plate System2Cleared 510(K)
- K161524Tangis Anterior Cervical Plate2Cleared 510(K)
- K160702ZION Anterior Cervical Fixation System2Cleared 510(K)
- K153097Belvedere™ Lateral Plating System2Cleared 510(K)
- K160604Cure™ Anterior Cervical Plate (ACP) System2Cleared 510(K)
- K153526Pyrenees Cervical Plate System2Cleared 510(K)
- K160522White Pearl Preferred Angle Anterior Cervical Plate2Cleared 510(K)
- K153042TRYPTIK2C-plate Anterior Cervical Plate System2Cleared 510(K)
- K160362Z-Span Plate System2Cleared 510(K)
- K151553Anterior Cervical Plate System2Cleared 510(K)
- K152239Zero-P Natural Plate System2Cleared 510(K)
- K152282Cam Lock Plating System2Cleared 510(K)
- K152623ATLANTIS Anterior Cervical Plate System2Cleared 510(K)
- K152455Amendia Cervical Plate System2Cleared 510(K)
- K152193Renovis Anterior Cervical Plate System2Cleared 510(K)
- K152281Pyrenees Cervical Plate System2Cleared 510(K)
- K152015Pyrenees Cervical Plate System2Cleared 510(K)
- K150759Hyper-C Anterior Cervical Plate System2Cleared 510(K)
- K150700ACP 1 Anterior Cervical Plating System2Cleared 510(K)
- K150983Pyrenees Cervical Plate System2Cleared 510(K)
- K150834Atrax Anterior Cervical Plating System2Cleared 510(K)
- K143688ASFORA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K143271CastleLoc-P Anterior Cervical Plate System2Cleared 510(K)
- K150666uNion Cervical Plate System2Cleared 510(K)
- K141332Captiva Spine SmartLOX Cervical Plate System2Cleared 510(K)
- K143028Azure Anterior Cervical Plate System2Cleared 510(K)
- K150036Blue Mountain Cervical Plate System2Cleared 510(K)
- K142212Pyrenees Cervical Plate System2Cleared 510(K)
- K143706FortiBridge Anterior Cervical Plate System2Cleared 510(K)
- K150449LITe Plate System2Cleared 510(K)
- K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System2Cleared 510(K)
- K143279LnK Anterior Cervical Plate System2Cleared 510(K)
- K143576Exactech Ambassador2Cleared 510(K)
- K142237Aviator Anterior Cervical Plate (ACP) System2Cleared 510(K)
- K143065NuVasive ALIF Buttress Plate System2Cleared 510(K)
- K142699LITe Plate System2Cleared 510(K)
- K141632ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K142060TRANSOM ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K141993NAKOMA ACP2Cleared 510(K)
- K133518MAXAN ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K133245GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM2Cleared 510(K)
- K141500OPTIO-C ANTERIOR CERVICAL SYSTEM2Cleared 510(K)
- K133911GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM2Cleared 510(K)
- K140417DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM2Cleared 510(K)
- K140260SKYHAWK LATERAL PLATE SYSTEM2Cleared 510(K)
- K133194DIAMOND RATTLESNAKE SYSTEM2Cleared 510(K)
- K140361META-C CERVICAL PLATE2Cleared 510(K)
- K140234ASPIRON ACP SYSTEM2Cleared 510(K)
- K140611TRINICA ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K132653NEOPLATE SPINE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K140742RELIANCE ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K133567UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K131521VELOX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K132310ASCOT2Cleared 510(K)
- K133475STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS2Cleared 510(K)
- K132994ANODYNE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K131025ARCHON ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K131533CAYMAN MI PLATE SYSTEM2Cleared 510(K)
- K132589ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)2Cleared 510(K)
- K132324SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST2Cleared 510(K)
- K132366SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS2Cleared 510(K)
- K132012TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K131200ASPIRON ACP SYSTEM2Cleared 510(K)
- K130868NUVASIVE DECADE LATERAL PLATE SYSTEM2Cleared 510(K)
- K131374TEMPUS(TM) CERVICAL PLATE SYSTEM2Cleared 510(K)
- K131512KATIA SYSTEM2Cleared 510(K)
- K131520NEXUS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K130427PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K130640ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K130825AZURE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K130202IRIS ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K130030ZAVATION CERVICAL PLATE SYSTEM2Cleared 510(K)
- K123578ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K122081NUVASIVE LONG LATERAL SPINAL SYSTEM2Cleared 510(K)
- K123167DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM2Cleared 510(K)
- K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K122733V2F ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K121791ZOU ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K121862REX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K121815NUVASIVE SAGE LATERAL PLATE SYSTEM2Cleared 510(K)
- K122497ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM2Cleared 510(K)
- K122910ARCHON ANTERIOR CERVICAL PLATE SYSTE,2Cleared 510(K)
- K121078VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K121801QUINTEX CERVICAL PLATING SYSTEM2Cleared 510(K)
- K122216RELIANCE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K121658ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)2Cleared 510(K)
- K121323MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE2Cleared 510(K)
- K121837NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM2Cleared 510(K)
- K112748SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K121060SPINE FRONTIER INDUS ACP SYSTEM2Cleared 510(K)
- K121049UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K112809BLUE MOUNTAIN CERVICAL PLATE2Cleared 510(K)
- K120515TEMPUS CERVICAL PLATE SYSTEM2Cleared 510(K)
- K120724PIONEER LATERAL PLATE SYSTEM2Cleared 510(K)
- K120092PLYMOUTH THORACOLUMBAR PLATE SYSTEM2Cleared 510(K)
- K113170CERVICAL PLATE2Cleared 510(K)
- K112861SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K112206CARDIFF ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K113509LEXUS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K113329K2M, PYRENEES CERVICAL PLATE SYSTEM2Cleared 510(K)
- K111132GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K112533ZAVATION CERVICAL PLATE SYSTEM2Cleared 510(K)
- K112724DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM2Cleared 510(K)
- K111796INVIZIA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K111528PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES2Cleared 510(K)
- K102406PASS ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K111135PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)2Cleared 510(K)
- K110990GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K111866NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K111410NUVASIVE LONG LATERAL SPINAL SYSTEM2Cleared 510(K)
- K103423MIS ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K103505ALTUM ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K102334TRANS1 AXIALIF PLUS2Cleared 510(K)
- K103750NUVASIVE TRAVERSE PLATE SYSTEM2Cleared 510(K)
- K103838FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM2Cleared 510(K)
- K103819PSL ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K103491SKYLINE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K103137VENUS ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K101353GOLDEN GATE ANTERIOR PLATE SYSTEM2Cleared 510(K)
- K103393POLARIS SPINAL SYSTEM2Cleared 510(K)
- K103068KING COBRA ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K103070GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +2Cleared 510(K)
- K102820APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2Cleared 510(K)
- K101848SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K100243QUINTEX CERVICAL PLATING SYSTEM2Cleared 510(K)
- K101255ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM2Cleared 510(K)
- K100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES2Cleared 510(K)
- K092695TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K090861MAMBO, MODEL CS 18XX-XX2Cleared 510(K)
- K101151REGENT ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K100265DIAMOND ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K100614HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES2Cleared 510(K)
- K100215ARCHIMED REMEDY CERVICAL PLATE2Cleared 510(K)
- K092765LANX ANTERIOR PLATING SYSTEM2Cleared 510(K)
- K093776INDUS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K092474PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS2Cleared 510(K)
- K093804NUVASIVE HELIX REVOLUTION ACP SYSTEM2Cleared 510(K)
- K100061CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX2Cleared 510(K)
- K100070UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K092531SPINE360 ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K092360ACP4 SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II2Cleared 510(K)
- K093200LIFE SPINE LUMBAR PLATE SYSTEM2Cleared 510(K)
- K091936BLADE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K091926CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM2Cleared 510(K)
- K092659SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-252Cleared 510(K)
- K092146XTEND ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K090751COMET ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K092070INTERPLATE C2Cleared 510(K)
- K091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K092108TRUSS THORACOLUMBAR PLATE SYSTEM2Cleared 510(K)
- K091396CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K091159SYNTHES ORACLE PLATE2Cleared 510(K)
- K091044SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K091253THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS2Cleared 510(K)
- K090415EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM2Cleared 510(K)
- K091071NUVASIVE LATERAL PLATE SYSTEM2Cleared 510(K)
- K090222PIONEER LUMBAR PLATE SYSTEM2Cleared 510(K)
- K090316MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081770BLACK WIDOW ANTERIOR BUTTRESS PLATE2Cleared 510(K)
- K083020STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K083562STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K083341NUVASIVE HELIX-T ACP SYSTEM2Cleared 510(K)
- K083663PACP2Cleared 510(K)
- K083338CARDIFF ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081548ANTERIOR BUTTRESS PLATE2Cleared 510(K)
- K082504APOLLO ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081380THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS2Cleared 510(K)
- K082187BIOMET ANTERIOR LUMBAR PLATE2Cleared 510(K)
- K082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K082037SEEPLATE CERVICAL PLATE SYSTEM2Cleared 510(K)
- K082070NUVASIVE LATERAL PLATE SYSTEM2Cleared 510(K)
- K082273UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081568ANTEGRA-T2Cleared 510(K)
- K081038ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081418SPINAL ELEMENTS BUTTRESS PLATE SYSTEM2Cleared 510(K)
- K081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K081567VERTEBRON SSP CERVICAL PLATING SYSTEM2Cleared 510(K)
- K081391VIP ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080773THOR ANTERIOR PLATING SYSTEM2Cleared 510(K)
- K073708FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080020ARCOFIX2Cleared 510(K)
- K080646C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080429MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEM2Cleared 510(K)
- K080690MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080191EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K080302CAYMAN BUTTRESS PLATE SYSTEM2Cleared 510(K)
- K073232INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX2Cleared 510(K)
- K073437THOR ANTERIOR PLATING SYSTEM2Cleared 510(K)
- K073349RELIANCE BUTTRESS WASHER SYSTEM2Cleared 510(K)
- K073530ACCIN ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K073275NUVASIVE HELIX MINI ACP SYSTEM2Cleared 510(K)
- K072943BUTREX BUTTRESS PLATING SYSTEM2Cleared 510(K)
- K073514TRANS1 AXIAL FIXATON SYSTEM2Cleared 510(K)
- K072703PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K073479KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K071905POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)2Cleared 510(K)
- K072231THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)2Cleared 510(K)
- K072407BODYFORM THORACIC FIXATION SYSTEM2Cleared 510(K)
- K071667SYNTHES VECTRA-ONE SYSTEM2Cleared 510(K)
- K072650IST ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K071151TENSION BAND ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K071416PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM2Cleared 510(K)
- K071990VALEO CERVICAL PLATE SYSTEM2Cleared 510(K)
- K072339NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K072546SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K070922MODIFICATION TO SPINAL USA VBR SYSTEM2Cleared 510(K)
- K071329NUVASIVE HELIX ACP SYSTEM2Cleared 510(K)
- K072040C-JAWS CERVICAL COMPRESSIVE MINI FRAME2Cleared 510(K)
- K070148GRAFT CONTAINMENT DEVICE2Cleared 510(K)
- K070891ALTIVA CLASSIC ACP SYSTEM2Cleared 510(K)
- K061385OSSTAPLE, OSSPLATE, OSSFORCE2Cleared 510(K)
- K063764SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM2Cleared 510(K)
- K070994EAGLE + ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K070681NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K070335SIMPLEX CERVICAL FIXATION SYSTEM2Cleared 510(K)
- K070273MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM2Cleared 510(K)
- K063430ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM2Cleared 510(K)
- K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K063100ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE2Cleared 510(K)
- K063544MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM2Cleared 510(K)
- K062590NUVASIVE ACP4 SYSTEM2Cleared 510(K)
- K062836CITADEL ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K062371PREVIEW ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K062643KINETIC ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K063158SYNTHES ANTEGRA SYSTEM2Cleared 510(K)
- K062831MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K062686UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM2Cleared 510(K)
- K062407GATEWAY THORACOLUMBAR PLATE SYSTEM2Cleared 510(K)
- K061353TRINICA ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K062310REFLEX HYBRID ACP SYSTEM2Cleared 510(K)
- K062110VERTEBRON SCP CERVICAL PLATE SYSTEM2Cleared 510(K)
- K061789LATERAL PLATE SYSTEM2Cleared 510(K)
- K061482ALTES BUTTRESS PLATING SYSTEM2Cleared 510(K)
- K061229UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM2Cleared 510(K)
- K061147OPTERYX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K061274VENTURE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K060442PYRENEES CERVICAL PLATE SYSTEM2Cleared 510(K)
- K060025SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K060491QUANTUM ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K060379EBI ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K053581NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM2Cleared 510(K)
- K052546AEGIS ANTERIOR LUMBAR PLATE SYSTEM2Cleared 510(K)
- K053053PACP SYSTEM2Cleared 510(K)
- K052763STELLA CERVICAL PLATE2Cleared 510(K)
- K052292SPIDER CERVICAL PLATING (SCP) SYSTEM2Cleared 510(K)
- K051815MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM2Cleared 510(K)
- K051531TECTONIC CERVICAL PLATE SYSTEM2Cleared 510(K)
- K052552HYBRID ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K051665SYNTHES VECTRA-T SYSTEM2Cleared 510(K)
- K052072THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES2Cleared 510(K)
- K051971OPTIMA SPINAL SYSTEM2Cleared 510(K)
- K051764T-PLATE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K050965TRANS1 AXIALIF SYSTEM2Cleared 510(K)
- K043548BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM2Cleared 510(K)
- K051039BASIS SPINAL SYSTEM2Cleared 510(K)
- K050892HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K050813ABC 2 SCREW2Cleared 510(K)
- K050588VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K050804MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K050774LANX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K050451SYNTHES VECTRA SYSTEM2Cleared 510(K)
- K050390TAMARACK ANTERIOR THORACOLUNBAR2Cleared 510(K)
- K050117MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM2Cleared 510(K)
- K042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM2Cleared 510(K)
- K043066PIONEER ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K043151MODIFICATION TO: CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K031782GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS2Cleared 510(K)
- K043181MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM2Cleared 510(K)
- K040426TRANS1 AXIAL FIXATION SYSTEM2Cleared 510(K)
- K042859KOBRA GPS FIXATION SYSTEM2Cleared 510(K)
- K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K042544UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K042922VENTURE ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K042499ORION ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K042317CERVICAL PLATE2Cleared 510(K)
- K042235ORION ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X2Cleared 510(K)
- K041625LTD POLYAXIAL FIXATION SYSTEM2Cleared 510(K)
- K042025MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K041205EXPEDIUM ANTERIOR SPINE SYSTEM2Cleared 510(K)
- K041447NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K041469ANTERIOR COMPACT SYSTEM2Cleared 510(K)
- K041105MACROPORE HYDROSORB SPINE SYSTEM2Cleared 510(K)
- K040844LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K041794C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K041460CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K033951RADIX CERVICAL PLATE2Cleared 510(K)
- K040721ASSURE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K040655SWIFT ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K041217MODIFICATION TO BONE GRAFT WASHER2Cleared 510(K)
- K040962MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K040017ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)2Cleared 510(K)
- K040397MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K040261REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K040401LANX ANTERIOR CERVIAL PLATE SYSTEM2Cleared 510(K)
- K033148ART ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K040197EAGLE ANTERIOR CERVIAL PLATE SYSTEM2Cleared 510(K)
- K040130ANTERIOR LUMBAR BUTTRESS SYSTEM2Cleared 510(K)
- K040003VERTEBRON SCP CERVICAL PLATE SYSTEM2Cleared 510(K)
- K033965SHIRAZ-ANTERIOR SYSTEM2Cleared 510(K)
- K031100SYNTHES VENTROFIX MIS SYSTEM2Cleared 510(K)
- K032815PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM2Cleared 510(K)
- K033844SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM2Cleared 510(K)
- K032102VERTELINK KOBRA SPINAL FIXATION SYSTEM2Cleared 510(K)
- K032752R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM2Cleared 510(K)
- K032368SONOMA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K031214CYCLONE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K024125HALM ZIELKE INSTRUMENTATION SYSTEM2Cleared 510(K)
- K023983MODIFICATION TO HIGHGATE CURVED ROD SYSTEM2Cleared 510(K)
- K031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM2Cleared 510(K)
- K032265CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K031702REFLEX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K032059MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM2Cleared 510(K)
- K031276SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM2Cleared 510(K)
- K021979SMISSON STABILIZATION SYSTEM2Cleared 510(K)
- K030667ENCORE ANTERIOR SPINAL STAPLE SYSTEM2Cleared 510(K)
- K030595BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K030866SYNTHES ANTERIOR CSLP SYSTEM2Cleared 510(K)
- K022965BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE2Cleared 510(K)
- K030500ORIA ZENITH2Cleared 510(K)
- K023377ORIA CERVICAL PLATES2Cleared 510(K)
- K030327ZEPHIR ANTERIOR CERVICAL SYSTEM2Cleared 510(K)
- K024326SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K021039BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM2Cleared 510(K)
- K022997SPECTRUM CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K022798CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS2Cleared 510(K)
- K022791SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM2Cleared 510(K)
- K021564INCOMPASS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K023133MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K022344TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K021761PREMIER ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K022605BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER2Cleared 510(K)
- K022419EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K022399BLACKSTONE SPINAL FIXATION SYSTEM SPACER2Cleared 510(K)
- K021461ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K020620BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)2Cleared 510(K)
- K020600BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)2Cleared 510(K)
- K021226MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM2Cleared 510(K)
- K020244SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)2Cleared 510(K)
- K020649ENVISION ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K020650MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K012045HIGHGATE CURVED ROD SYSTEM2Cleared 510(K)
- K014107ENDIUS CERVICAL PLATE SYSTEM2Cleared 510(K)
- K013979SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K012184BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K013665PYRAMID ANTERIOR PLATE FIXATION SYSTEM2Cleared 510(K)
- K013558BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW2Cleared 510(K)
- K013439ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K013877CODMAN SLIM-LOC SYSTEM2Cleared 510(K)
- K012916FRONTIER ANTERIOR SCOLIOSIS SYSTEM2Cleared 510(K)
- K012881C3 ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K011556MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM2Cleared 510(K)
- K012305MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K010911MACROPORE OS SPINAL SYSTEM2Cleared 510(K)
- K010639CONVERGENCE CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K010466TETHER ACFS2Cleared 510(K)
- K002824MACS MODULAR ANTERIOR CONSTRUCT SYSTEM2Cleared 510(K)
- K010115REFLEX ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K010003EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K003061SYNTHES USS (10.0MM SIDE OPENING SCREWS)2Cleared 510(K)
- K002980MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K002858XIA SPINE SYSTEM2Cleared 510(K)
- K002592INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K002371K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM2Cleared 510(K)
- K001847ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K001864SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K001357MODIFICATION TO OMEGA 21 SYSTEM2Cleared 510(K)
- K001844MODIFICATION TO CENTAUR SPINAL SYSTEM2Cleared 510(K)
- K001794EBI ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K994239ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K993066WINDOW CERVICAL DYNAMIC PLATE SYSTEM2Cleared 510(K)
- K001272XIA SPINE SYSTEM2Cleared 510(K)
- K993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K000486ABC CERVICAL PLATING SYSTEM2Cleared 510(K)
- K000742SYNTHES ANTERIOR CSLP SYSTEM2Cleared 510(K)
- K000536SYNTHES ANTERIOR CSLP SYSTEM2Cleared 510(K)
- K994347CENTAUR SPINAL SYSTEM2Cleared 510(K)
- K000634ROD TO ROD CROSS BRACES2Cleared 510(K)
- K000009SPIRAL RADIUS RODDING SYSTEM2Cleared 510(K)
- K000513MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K994122BONE GRAFT WASHER, MODEL 9090114 - 90901182Cleared 510(K)
- K994383DOGBONE ACFS2Cleared 510(K)
- K992012WILTSE SYSTEM2Cleared 510(K)
- K993030MODIFICATION TO ISOLA SPINAL SYSTEM2Cleared 510(K)
- K990959K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM2Cleared 510(K)
- K993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K993822EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K992792XIA SPINAL SYSTEM C-C ADAPTOR2Cleared 510(K)
- K992784NEXT GENERATION RODDING SYSTEM2Cleared 510(K)
- K993181HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS2Cleared 510(K)
- K992168MOSS MIAMI 6.35MM POLYAXIAL SCREW2Cleared 510(K)
- K992110PREMIER ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K991678WHITESIDE BIOMECHANICS SPINAL SYSTEM2Cleared 510(K)
- K992344OSTEONICS ACCP SYSTEM LINE EXTENSION2Cleared 510(K)
- K991092EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM2Cleared 510(K)
- K990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K984251XIA SPINE SYSTEM2Cleared 510(K)
- K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K982006MICOMED - HALM ZIELKE INSTRUMENTATION2Cleared 510(K)
- K982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K984342ANTERIOR CERVICAL PLATING SYSTEM2Cleared 510(K)
- K983622BODYFORM THORACO-LUMBAR FIXATION SYSTEM2Cleared 510(K)
- K983899THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)2Cleared 510(K)
- K982443DOC VENTRAL CERVICAL STABILIZATION SYSTEM2Cleared 510(K)
- K974885BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K981008SIMAL CERVICAL STABILIZATION SYSTEM2Cleared 510(K)
- K980228UNIVERSITY PLATE ANTERIOR SYSTEM2Cleared 510(K)
- K973854ORION ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K974706AESCULAP ABC CERVICAL PLATING SYSTEM2Cleared 510(K)
- K974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS2Cleared 510(K)
- K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM2Cleared 510(K)
- K974435MICHELSON ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K973923EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM2Cleared 510(K)
- K973060DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM2Cleared 510(K)
- K971730DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM2Cleared 510(K)
- K972718M-2 ANTERIOR PLATE SYSTEM2Cleared 510(K)
- K970635TITANIUM SPINAL ROD SYSTEM2Cleared 510(K)
- K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)2Cleared 510(K)
- K963780DUAL ROD ANTERIOR FIXATOR SYSTEM2Cleared 510(K)
- K971248KANEDA SR ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K970955ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM2Cleared 510(K)
- K970806ACPII ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K964797EBI SPINELINK SYSTEM2Cleared 510(K)
- K970462ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM2Cleared 510(K)
- K965193LIBERTY ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM2Cleared 510(K)
- K953978ANTERIOR DYNAMIZED SYSTEM2Cleared 510(K)
- K964623TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K962486DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM2Cleared 510(K)
- K963655CD HORIZON ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K955730EBI ANTERIOR CERVICAL SPINE SYSTEM2Cleared 510(K)
- K940744SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION2Cleared 510(K)
- K953730CODMAN ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K950011COHORT(TM) ANTERIOR PLATE SYSTEM (APS)2Cleared 510(K)
- K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION2Cleared 510(K)
- K950709SYNERGY TI ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K950209J.B.S. ANTERIOR SPINE SYSTEM(R)2Cleared 510(K)
- K943725UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM2Cleared 510(K)
- K945700SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM2Cleared 510(K)
- K943819ISOLA ANTERIOR SYSTEM2Cleared 510(K)
- K943694EBI ANTERIOR CERVICAL SPINE SYSTEM2Cleared 510(K)
- K943523ANTERIOR CERVIAL PLATING SYSTEM2Cleared 510(K)
- K941367WEBB-MORLEY SPINE SYSTEM2Cleared 510(K)
- K934756CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM2Cleared 510(K)
- K934429ANTERIOR SPINE SYSTEM2Cleared 510(K)
- K936269CASPAR TITANIUM ALLOY BONE SCREWS2Cleared 510(K)
- K931653SPINE-TECH CERVICAL FIXATION SYSTEM2Cleared 510(K)
- K925351SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE2Cleared 510(K)
- K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE2Cleared 510(K)
- K930807SENTRY ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K922855SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS2Cleared 510(K)
- K923703KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV2Cleared 510(K)
- K923242CROSSLINK AXIAL AND OFFSET PLATES2Cleared 510(K)
- K922543Z-PLATE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K923446STERILE DYNA LOK ANTERIOR PLATING SYSTEM2Cleared 510(K)
- K922087ANTERIOR CERVICAL PLATE SYSTEM2Cleared 510(K)
- K914362TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS2Cleared 510(K)
- K913730AESCULAP TITANIUM BONE PLATES2Cleared 510(K)
- K910874THORACIC ANTERIOR SPINAL FIXATION PLATE2Cleared 510(K)
- K905023AMSET LOCKING PLATE SYSTEM2Cleared 510(K)
- K901507MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)2Cleared 510(K)
- K910681SIMMONS PLATING SYSTEM2Cleared 510(K)
- K904446CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)2Cleared 510(K)
- K873826ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION2Cleared 510(K)
- K853033HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM2Cleared 510(K)
- K851414SEGMENTAL SPINAL RODS2Cleared 510(K)
- K841189OEC/REZAIAN SPINAL FIXATOR2Cleared 510(K)
- K831982BRADFORD SPINAL FRACTURE FIXATION SYS2Cleared 510(K)
- K820034ANTERIOR DISTRACTION SYSTEM2Cleared 510(K)
- K802222ANTERIOR KYPHOSIS DISTRACTION DEVICE2Cleared 510(K)
- K792352SYNTHES CERVICAL VERTABRAE PLATES2Cleared 510(K)
- K790941D.T.T. LOCK SCREW INSERTER2Cleared 510(K)
- K790404DTT SYSTEM2Cleared 510(K)
- K782061SPINAL SURGERY INSTRUMENTATION2Cleared 510(K)
- 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
BALTEUM - ONE™ Lumbar Plate System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K213820
- 510(k) Type
- Traditional
- Applicant
- Huvexel Co., Ltd
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/25/2022
- Days to Decision
- 107 days
- Submission Type
- Summary