510(k) Report

Devices descending from K130177

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K223326Axiom PSR SystemRestor3D202301
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—