510(k) Report

Devices descending from K040080

8 later devices reach Aesculap Absorbable Craniofix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation20131—
+1K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104—
+1K091692Aesculap Peek CraniofixAesculap, Inc.20100—
+2K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.20230—
+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—