510(k) Report

Devices descending from K123942

5 later devices reach Stryker Ivas Balloon Catheter through their predicates, nearest generation first.

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