510(k) Report

Devices descending from K121786

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+1K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—