510(k) Report

Devices descending from K173472

5 later devices reach MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231515MySpine Cervical GuidesMedacta International S.A.20230—
+1K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+1K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+1K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+2K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—