510(k) Report

Devices descending from K132788

12 later devices reach Myspine Pedicle Screw Placement Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+1K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+1K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+2K231515MySpine Cervical GuidesMedacta International S.A.20230—
+2K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+2K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+2K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+2K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+3K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+3K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+3K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+4K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—