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Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is primarily a 510(k) submission letter and a summary of safety and effectiveness information for a medical device (Synthes (USA) Locking Reconstruction Plate with Condylar Head). It details the device's description, intended use, classification, and regulatory status, but it does not include details on performance acceptance criteria or study results to demonstrate those criteria were met.

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