(84 days)
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws 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.
Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that a device meets acceptance criteria. The document is a 510(k) summary for Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws, outlining its indications for use, device description, and substantial equivalence to predicate devices. It also includes an FDA response confirming substantial equivalence.
Therefore, I cannot provide the requested table or answer the specific questions about a study based on the given information.
To answer your request, a document detailing device performance data, acceptance criteria, and specific study methodologies would be required.
§ 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.