510(k) Report

Devices descending from K150362

441 later devices reach NuVasive CoRoent Small Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K210728CONDUIT InstrumentsMedos International SARL20215—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—