510(k) Report

Devices descending from K033837

896 later devices reach Stryker Spine Vertebral Body Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+7K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+7K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+7K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+7K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+7K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+7K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+8K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K261049Scala® TLSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+8K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+8K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K230026SqualeImplanet, S.A.20230—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—