510(k) Report

Devices descending from K193214

3 later devices reach WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+2K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—