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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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