510(k) Report

Devices descending from K031511

902 later devices reach Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402