510(k) Report

Devices descending from K031761

3 later devices reach Synthes (Usa) New/Sterial Orbital Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K180249OmniPore DUROMAX Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA20180—
+1K140978Osteomed Low Profile Orbital Floor Plate SystemOsteomed20140—