510(k) Report

Devices descending from K063067

4 later devices reach Confidence Fenestrated Introducer Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+1K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd.20070—
+1K070351Space 360 Delivery SystemDfine, Inc.20071—
+2K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—