510(k) Report

Devices descending from K151322

226 later devices reach Amendia Interbody Fusion Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+1K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+1K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+1K162496Foundation 3D InterbodyCorelink, LLC201782—
+1K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+1K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+2K183064TxTi IBF SystemInnovasis, Inc.2019481
+2K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+2K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K223326Axiom PSR SystemRestor3D202301
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200312Tryptik TiSpineart20202—
+3K191134IB3D AlifMedicrea International SA20191—
+3K1803473d CageFims Co., Ltd.20190—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+4K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—