(441 days)
The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples:
- Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair Pieces
Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Epitec™ Titanium Implant System. It does not contain the acceptance criteria or details of any study proving the device meets acceptance criteria.
The letter states that the device has been found substantially equivalent to predicate devices, allowing it to be marketed, but does not include information about performance studies or acceptance criteria.
Therefore, I cannot provide the requested information based on the input document.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.