510(k) Report

Devices descending from K043518

27 later devices reach Radiopaque Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151125AVAflex Vertebral Balloon SystemCare Fusion20151—
+1K131820Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Care Fusion20138—
+1K131824Avaflex Vertebral Balloon SystemCare Fusion20133—
+1K103064Avamax Vertebral BalloonCare Fusion201122—
+1K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion201023—
+1K090211Inflatable Bone TampCardinal Health, Inc.200924—
+2K200763Osteo-site Vertebral BalloonIzi Medical20200—
+2K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+2K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation20160—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K150523AVAmax Vertebral BalloonCare Fusion20151—
+2K141419ZvplastyZavation, LLC2014036
+2K122533Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc.20128—
+2K110604VBB SystemSynthes201111
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K141930Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC20146—
+3K140937Osseoflex SBOsseon, LLC20147—
+3K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K191596Arcadia Balloon CatheterMerit Medical Systems, Inc.20190—
+4K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlOsseon, LLC20154—
+5K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG20203—
+6K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd.20232—
+7K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.20250—