510(k) Report

Devices descending from K140937

7 later devices reach Osseoflex SB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141930Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC20146—
+2K191596Arcadia Balloon CatheterMerit Medical Systems, Inc.20190—
+2K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlOsseon, LLC20154—
+3K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG20203—
+4K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd.20232—
+5K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.20250—