510(k) Report

Devices descending from K150607

4 later devices reach Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG20203—
+2K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd.20232—
+3K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.20250—