(77 days)
The PowerPro® Pneumatic System consists of handpieces and attachments intended to be used for cutting, drilling, tapping, reaming, and driving screws and pins in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
The PowerPro® Pneumatic System is a pneumatically powered system consisting of handpieces and attachments for cutting bone in various large and small bone procedures. The PowerPro® Pneumatic handpieces are pistol-grip handpieces. The handpieces utilize various attachments, such as blades, burs, drills and routers that are also used with Linvatec's PowerPro® Electric and Battery Systems.
This document is a 510(k) Summary of Safety and Effectiveness for the PowerPro® Pneumatic System. It states that the PowerPro® Pneumatic System is substantially equivalent to predicate devices and does not raise any new safety or effectiveness issues. However, it does not include specific acceptance criteria or details of a study demonstrating the device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than a detailed performance study with defined acceptance criteria.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.