510(k) Report

Devices descending from K120819

206 later devices reach Stalif C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+1K192906Mecta-C Stand AloneMedacta International S.A.20201—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+1K162531Sterispine CCSafe Orthopaedics20160—
+1K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+1K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+1K133200Stalif C (R)Centinel Spine, Inc.201410—
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+1K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+2K240699SCARLET® AC-TiSpineart SA20240—
+2K240715Idys® C ZP 3DTiClariance20240—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K212562Idys-C ZP 3DTiClariance, SA20211—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K172065Scarlet AC-TSpineart20172—
+2K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221578Hexanium ACIFSpinevision, S.A.S.20224—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—