510(k) Report

Devices descending from K081813

4 later devices reach Universal Compression Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—