510(k) Report

Devices descending from K193368

3 later devices reach Smart Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+1K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+1K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—