510(k) Report

Devices descending from K182711

4 later devices reach Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261058CraniUS PlateCraniUS, LLC20261—
+1K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+1K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+2K262874CraniUS PlateCraniUS, LLC20260—