510(k) Report

Devices descending from K130177

628 later devices reach Anatomic Peek Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+1K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+1K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp.2014532—
+1K142251AVS AS PEEK SpacerStryker Corporation2014161—
+1K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+1K142079Stalif Cti, Stalif CCentinel Spine, Inc.2014276—
+1K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+1K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+1K133653Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2014286—
+2K242303MOD-COrthomod, LLC20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+2K230026SqualeImplanet, S.A.20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K212358Romero Cervical CageSpineup, Inc.20226—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+2K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K172568CervagePrecifit Medical, Ltd.20181—
+2K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+2K172065Scarlet AC-TSpineart20172—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K161407Ascential IBD PEEKc SpacerStryker Spine201627—
+2K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+2K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+2K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+2K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp.20155—
+2K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+2K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K150053STALIF C; STALIF C-TiCentinel Spine, Inc.2015273—
+2K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K250560BEE HANGMedical GmbH20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200312Tryptik TiSpineart20202—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—