(73 days)
The Opus Magnum Anchor and Inserter is intended for the fixation of soft tissue to bone for the following indications: SHOULDER (l) 1.) Rotator Cuff Repair
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Opus Magnum Anchor and Inserter." This type of document declares that a device is substantially equivalent to a predicate device and can be marketed, but it does not contain information about acceptance criteria or specific study results showing the device meets those criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document. The document describes the regulatory approval process but does not include the detailed technical and clinical study data that would inform such criteria and performance reports.
§ 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.