510(k) Report

Devices descending from K180963

3 later devices reach Roccia Alif, Roccia Tlif through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+1K190680Favo S-TlifSilony Medical GmbH20190—
+2K221172FOCUS Interbody SystemOc Medical Devices20220—