510(k) Report

Devices descending from K223709

2 later devices reach Kyphoplasty Balloon Catheter through their predicates, nearest generation first.

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