510(k) Report

Devices descending from K062083

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122444Cervical CageEisertech, LLC201222—
+4K122317Tetris IISignus Medizintechnik GmbH20122—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+4K121116Plateau Spacer SystemLife Spine201213—
+4K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+4K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+4K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+4K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+4K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K103369Vault Alif SystemSpinal USA201110—
+4K110045Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc.20110—
+4K102277Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201098—
+4K101301Stalif MidlineCentinel Spine2010474—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+4K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+4K092574Esl Spinal SystemEbi, L.P.2010181—
+4K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+4K092336C-Thru Spinal SystemEbi, L.P.2009492—
+4K091381Ibex Spinal SystemEbi, L.P.2009181—
+4K081711Lucent Magnum+Spinal Elements, Inc.20080—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251016MectaLIF 3D MetalMedacta International S.A.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232347MagnetOs GranulesKuros Biosciences B.V20242—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—