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For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.

These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared. In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.

This is not an AI/ML device. This is a 510(k) premarket notification for a medical device called "Wrist Fusion Plate". The document does not contain information about acceptance criteria or a study proving the device meets them because it is a traditional medical device, not an AI/ML product. Therefore, it is unable to answer the question as it pertains to AI/ML device testing and evaluation.

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