510(k) Report

Devices descending from K141314

38 later devices reach Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240699SCARLET® AC-TiSpineart SA20240—
+1K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+1K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+1K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+1K172065Scarlet AC-TSpineart20172—
+1K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K221578Hexanium ACIFSpinevision, S.A.S.20224—
+2K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—