(167 days)
Citieffe External Fixator ST.A.R. 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; l - Post traumatic reconstruction for joint stiffness. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
Citieffe External Fixator ST.A.R. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (ST.A.R. 90 F4 External Fixator) and outlines its intended use. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval and indications for use, not performance studies or acceptance criteria.
§ 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.