510(k) Report

Devices descending from K053623

5 later devices reach Nfix Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080876DVX Spine SystemBk Meditech, Co., Ltd.20081—
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K090424DVX Spine SystemBk Meditech, Co., Ltd.20090—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K072685Ngarde SystemN Spine, Inc.200709