510(k) Report

Devices descending from K051659

790 later devices reach Semial Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250560BEE HANGMedical GmbH20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—