510(k) Report

Devices descending from K201420

2 later devices reach Republic Spine Dark Star Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—