510(k) Report

Devices descending from K193100

4 later devices reach RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+1K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—