510(k) Report

Devices descending from K061041

3 later devices reach US Spine Facet Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc.20110—
+1K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—