510(k) Report

Devices descending from K091531

361 later devices reach Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+1K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K101171Orthovita Peek SpacerOrthovita, Inc.2011225—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K140280ForticoreNanovis, LLC20149—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K122444Cervical CageEisertech, LLC201222—
+2K120486Avs as Peek SpacerStryker Spine2012224—
+3K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200312Tryptik TiSpineart20202—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K162496Foundation 3D InterbodyCorelink, LLC201782—
+3K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K142251AVS AS PEEK SpacerStryker Corporation2014161—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K242303MOD-COrthomod, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—