510(k) Report

Devices descending from K111593

2 later devices reach Guardian Inflatable Bone Expander System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143006GUARDIAN-SG Inflatable Bone Expander SystemBm Korea Co., Ltd.20151—
+2K162283DCM Kyphoplasty SystemDragon Crown Medical Co., Ltd.20170—