510(k) Report

Devices descending from K130573

251 later devices reach Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K263049SABER-C SystemElevation Spine20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—