510(k) Report

Devices descending from K212498

7 later devices reach Stable-L Standalone Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+1K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+2K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+2K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K261279DeltaNEC Interbody SystemNexus Spine20260—