510(k) Report

Devices descending from K090224

7 later devices reach Fortex Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited20181—
+1K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+1K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited20200—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+2K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—