510(k) Report

Devices descending from K842493

3 later devices reach Agee External Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984442Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147Hand Biomechanics Lab, Inc.199921
+2K033112Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NSHand Biomechanics Lab, Inc.20030—
+2K030519Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNSHand Biomechanics Lab, Inc.20030—