510(k) Report

Devices descending from K062617

3 later devices reach Modification to Inion Otps Biodegradable Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+2K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+2K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—