510(k) Report

Devices descending from K170989

2 later devices reach Dymaxeon Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—