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The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.

The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.

The Arthrex Fracture Plates and Screws are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50mm to 244mm in length. The accompanying screws are 2.0mm to 6.7mm in diameter.

The provided document is a 510(k) premarket notification for Arthrex Fracture Plates and Screws. It describes a medical device, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and study data for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices for bone fixation plates and screws, including proposed sterilization methods and line extensions.

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