510(k) Report

Devices descending from K131824

3 later devices reach Avaflex Vertebral Balloon System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+1K151125AVAflex Vertebral Balloon SystemCare Fusion20151—
+2K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation20160—