510(k) Report

Devices descending from K010361

6 later devices reach Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104—
+1K013000Medtronic Invisx Burr Hole Lock, Model 60520Medtronic Neurosurgery20010—
+2K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L20133—
+3K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L20240—
+3K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+3K160739Cranial COVERNeos Surgery S.L20161—