510(k) Report

Devices descending from K103582

8 later devices reach Kelyniam Custom Skull Implant (Csi) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+1K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+1K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+1K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+2K261058CraniUS PlateCraniUS, LLC20261—
+2K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+2K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+3K262874CraniUS PlateCraniUS, LLC20260—