510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K133192Mectalif TipeekMedacta International201416—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K130445Vault Alif SystemSpinal USA20139—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K103743Concorde Curve SystemJohnson & Johnson20110—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+5K263049SABER-C SystemElevation Spine20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261049Scala® TLSpineart SA20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—