510(k) Report

Devices descending from K173180

3 later devices reach Mega Plus Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—