510(k) Report

Devices descending from K954682

5 later devices reach Washer, Bolt, Nut, Orthopedic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—