510(k) Report

Devices descending from K113770

6 later devices reach Orthofix Galaxy Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+1K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+1K141760Orthofix Galaxy WristOrthofix Srl201401
+1K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K170146Galaxy UNYCO SystemOrthofix Srl20170—