510(k) Report

Devices descending from K010344

5 later devices reach Adjustable Large Fixator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC20112—
+1K012623Reprocessed External Fixation DeviceAlliance Medical Corp.20021—
+2K213905ONX Large External Fixation SystemOrthonovis, Inc.20220—
+2K171211OIC External Fixation SystemOrthopaedic Implant Company20170—
+2K032058Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp.20030—