510(k) Report

Devices descending from K191961

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231710OW100SSoftwave/Trt, LLC20231—
+1K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG20211—
+1K200926OrthoGold 100Tissue Regeneration Technologies, LLC20202—
+2K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A20250—
+2K233937OW100SSoftwave/Trt, LLC20240—