510(k) Report

Devices descending from K210539

4 later devices reach CoreLink Midline Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+1K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+1K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—