510(k) Report

Devices descending from K051205

829 later devices reach Stryker Spine Avs Asl Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+6K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891