(44 days)
Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.
The device is a flexible titanium nail for orthopedic implantation.
The provided text is a 510(k) summary for the FLEX-NAILS device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
This 510(k) summary is a regulatory filing that declares the device sufficiently similar to existing legal devices to be marketed, rather than a detailed report of clinical or performance studies.
Therefore, I cannot provide the requested information based on the given text.
§ 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.