510(k) Report

Devices descending from K161335

3 later devices reach Dual Top Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231913T-FITTechwin Co., Ltd.20240—
+1K210559ATOZ Mini-ScrewMk Meditech, Inc.20210—
+1K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd.20200—