510(k) Report

Devices descending from K153296

4 later devices reach MEDINAUT Kyphoplasty System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.20240—
+1K192335TRACKER Kyphoplasty SystemGS Medical Co., Ltd.20191—
+1K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+2K211797TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd.20210—