510(k) Report

Devices descending from K062424

7 later devices reach Confidence EX High Viscosity Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd.20070—
+1K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+1K063067Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd.20064—
+2K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+2K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+2K070351Space 360 Delivery SystemDfine, Inc.20071—
+3K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—