510(k) Report

Devices descending from K001096

6 later devices reach Burr Hole Cover, Model XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123163Neuropace Burr Hole Cover Model 8110NeuroPace, Inc.20135—
+2K160739Cranial COVERNeos Surgery S.L20161—
+2K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical20161—
+2K141368Neuropace Burr Hole CoverNeuroPace, Inc.20142—
+3K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+3K181382GuardianTM Burr Hole Cover SystemSt Jude Medical20180—