510(k) Report

Devices descending from K983885

2 later devices reach Burr Hole Covers, Craniomaxillofacial Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160739Cranial COVERNeos Surgery S.L20161—
+2K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—