510(k) Report

Devices descending from K121102

2 later devices reach Osteosymbionics Peek Cranial Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+2K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—