510(k) Report

Devices descending from K151934

9 later devices reach ROI-C Titanium-Coated Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—