510(k) Report

Devices descending from K191537

3 later devices reach eCarbon IBDs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+1K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—