510(k) Report

Devices descending from K162134

2 later devices reach ENNOVATE Spinal System through their predicates, nearest generation first.

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