510(k) Report

Devices descending from K951303

28 later devices reach SFC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222637TriMed Wrist Fixation System 3TriMed, Inc.202231
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+1K091156Trimed Sterile ProductTriMed, Inc.20090—
+1K030877Trimed Radial BulletTri-Med, Inc.20040—
+1K010545TBWTri-Med, Inc.200110—
+2K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+2K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S)…TriMed, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+2K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+2K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar…TriMed, Inc.20250—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K262649Alians ForearmNewclip Technics20260—
+3K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+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—