510(k) Report

Devices descending from K222194

5 later devices reach Baby Gorilla®/Gorilla® Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+1K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+1K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—