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function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot.

The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidew res and the proposed device are available in either stainless steel or Titanium alloy. Both function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed

This document describes acceptance criteria and a study for "Guide Wires for Cannulated Screws." However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any study design details related to demonstrating the device meets performance criteria.

The provided text only constitutes a 510(k) summary for the "Guide Wires for Cannulated Screws," focusing on demonstrating substantial equivalence to a predicate device (Synthes guidewires). It describes the devices' materials, function, and design, but not their performance in a medical setting or any testing conducted beyond basic design equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The input lacks all the necessary information.

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