510(k) Report

Devices descending from K132044

3 later devices reach Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation… through their predicates, nearest generation first.

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