510(k) Report

Devices descending from K080522

113 later devices reach Synthes 3.5 MM LCP Distal Tibia T Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—