510(k) Report

Devices descending from K091406

6 later devices reach Atlas Spine Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183659Omnia Medical Rotary PLIF SystemOmnia Medical, LLC20190—
+1K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+2K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K181829Velofix TLIF CageU&I Corporation20181—