510(k) Report

Devices descending from K140010

11 later devices reach Fortress Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+1K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+1K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+1K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+1K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—