510(k) Report

Devices descending from K152974

22 later devices reach ORTHOLOC® 3Di Foot Plating Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+1K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+1K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+1K200062Foot and Ankle SystemLeith Medical, LLC20210—
+1K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+1K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+1K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+2K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+2K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+2K211843PolyLock Plating SystemFusion Orthopedics20220—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—