510(k) Report

Devices descending from K143350

10 later devices reach Nile Alternative Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+1K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+1K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+1K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—