510(k) Report

Devices descending from K212547

2 later devices reach Quick-Start Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231819Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics Limited20231—
+2K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd.20250—