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The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.

The proposed devices of Reconstruction Locking Plate and 3.5mm Locking Screw are intended to treat fractures of various bones, including the clavicle and pelvis. They are made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with 3.5mm major diameter, which are applied with the reconstruction locking plates together. The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.