510(k) Report

Devices descending from K162138

135 later devices reach NuVasive CoRoent Small Ti-C System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+1K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+1K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—