510(k) Report

Devices descending from K152557

2 later devices reach Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L.20171—
+2K200763Osteo-site Vertebral BalloonIzi Medical20200—