510(k) Report

Devices descending from K123939

3 later devices reach S4 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—