510(k) Report

Devices descending from K083118

458 later devices reach Spinal Usa Anterior Cervical Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—