510(k) Report

Devices descending from K210451

2 later devices reach OrthoGold 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210166Omnispec ED1000Medispec, Ltd.20230—
+1K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—