510(k) Report

Devices descending from K143188

8 later devices reach 3.Omm Biomet Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+1K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—