510(k) Report

Devices descending from K192449

3 later devices reach Joline Kyphoplasty System Allevo through their predicates, nearest generation first.

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