(70 days)
The Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.
The technological characteristics of the Large Fragment Locking Plating System are the same as the predicate devices including design and material.
The provided text is a 510(k) summary for a medical device called the "Large Fragment Locking Plating System". It does not contain information about acceptance criteria, device performance, study details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. Performance data, in the sense of a clinical or analytical study with defined acceptance criteria and results, is not present.
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§ 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.