510(k) Report

Devices descending from K120903

6 later devices reach Congruent Bone Plate System: Acu-Loc 2 Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233311Acumed Wrist Plating SystemAcumed, LLC20243—
+1K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+2K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—