510(k) Report

Devices descending from K151692

2 later devices reach BioArchitects Patient Specific Cranial/Craniofacial Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)20260—
+1K252251Easymade-TICG Bio Co., Ltd.20260—