510(k) Report

Devices descending from K162419

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+1K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+2K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+2K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+3K231515MySpine Cervical GuidesMedacta International S.A.20230—
+3K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+3K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—