510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+4K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+4K083661Avs TL Peek SpacersStryker Corp.2009757—
+4K083475Lucent MagnumSpinal Elements, Inc.2009834—
+4K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+4K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+4K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+4K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+5K263049SABER-C SystemElevation Spine20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251016MectaLIF 3D MetalMedacta International S.A.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K243670Idys® LIFClariance20240—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+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—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—