510(k) Report

Devices descending from K100743

4 later devices reach Atlas Spine Pivoting System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+1K172419Velofix™ TLIF CageU&I Corporation20172—
+2K183243Velofix TLIF CageU&I Corporation20190—
+2K181829Velofix TLIF CageU&I Corporation20181—