(27 days)
This device is used in the general management of fractures and reconstructive surgery.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Helical Compression Anchor System, Cannulated, Model 7.3mm". This document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and provides contact information for further assistance.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the FDA's decision letter.
§ 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.