510(k) Report

Devices descending from K130430

5 later devices reach Ivas 10MM and 15MM Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20181—
+1K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L.20162—
+2K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20180—
+2K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L.20171—
+3K200763Osteo-site Vertebral BalloonIzi Medical20200—