510(k) Report

Devices descending from K213591

5 later devices reach ANTHEM® Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+1K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+2K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+2K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—