510(k) Report

Devices descending from K130177

628 later devices reach Anatomic Peek Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+3K162496Foundation 3D InterbodyCorelink, LLC201782—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K163265Kepler IIOrbbo Surgical, LLC20170—
+3K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162587Roccia® AcifSilony Medical GmbH20171—
+3K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody SystemSpinal Elements, Inc.201646—
+3K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K151939COALITION SpacersGlobus Medical, Inc.2016152—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K263049SABER-C SystemElevation Spine20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K230583Tryptik TiSpineart SA20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—