510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+1K052170Seaspine VBR SystemSeaspine, Inc.200513—
+1K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+1K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+1K040731Stryker Spine Vertebral SpacerStryker Spine2004895—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K071726ZUMASeaspine, Inc.200712—
+2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+2K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+2K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K124034Mectalif AnteriorMedacta International201311—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K121581Box Peek VBR System,Innovasis, Inc.20121—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K103666Lanx LateralLanx, Inc.2011238—
+3K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+3K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+3K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+3K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+3K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+3K073502Vertebron VBR SystemVertebron, Inc.200812—
+3K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+3K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+3K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+3K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+3K053508Synfix-LRSynthes Spine Co.Lp2006391
+3K051781Graftcage TLXOsteotech, Inc.20050Class I
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—