510(k) Report

Devices descending from K101235

4 later devices reach Cranial Loop Cranial Bone Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L20133—
+2K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L20240—
+2K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+2K160739Cranial COVERNeos Surgery S.L20161—