510(k) Report

Devices descending from K130116

16 later devices reach Superior Lateral Variax Clavicle Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+1K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—