510(k) Report

Devices descending from K110733

481 later devices reach Daytona Anterior Cervical Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—