510(k) Report

Devices descending from K944092

11 later devices reach Additional Accessories for the Orthofix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+1K071395Biomet Vision Footring SystemBiomet Manufacturing Corp20071—
+1K023714Reprocessed External Fixation DeviceAlliance Medical Corp.20031—
+2K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+2K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+2K141760Orthofix Galaxy WristOrthofix Srl201401
+2K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K093753Mdpo Frame SystemMdpo, LLC20100—
+2K052065Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp.20050—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—