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Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.

The Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes LCP plates to stabilize fractures. The plates are available in stainless steel and titanium.

The provided text is related to a 510(k) premarket notification for a medical device called "Synthes (USA) 3.5mm Locking Attachment Plates." This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

The content is a regulatory approval letter and a summary of the device for submission to the FDA, focusing on establishing substantial equivalence for market clearance. It typically does not include raw study data or detailed performance metrics.

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