510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+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—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+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—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192993Scarlet AL-TSpineart20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—