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Fixation of orthopaedic fractures to long bones and the pelvis involving severe trauma with loss or damage to soft tissues, infection and/or loss of bone stock.
Centrafix® External Fixator
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Centrafix® External Fixator." This document is a regulatory approval letter and does not contain information about the acceptance criteria, device performance, or any studies conducted.
Therefore, I cannot extract the requested information. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.