510(k) Report

Devices descending from K181399

5 later devices reach FIREFLY® Pedicle Screw Navigation Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+1K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+2K231515MySpine Cervical GuidesMedacta International S.A.20230—
+2K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+2K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—