510(k) Report

Devices descending from K153250

32 later devices reach Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+1K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+1K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+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—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—