510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K200429BEE CagesNGMedical GmbH202111—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192897icotec Cervical CageIcotec AG20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192993Scarlet AL-TSpineart20201—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—