510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+5K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232315Catalyst Bone Void FillerOssdsign AB20237—
+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—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K230026SqualeImplanet, S.A.20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K200919Idys ALIF 3DTiClariance20210—