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The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.

This traditional 510(k) submission adds configurations of the previously cleared Tyber Medical Trauma Screws under K192975 and K153575. The Tyber Medical Trauma Screw is designed to allow compression and fixation between two adjacent bone segments. The screw is available with thread diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, and 9.0mm. The screw is configured to have either full thread, long thread, or short thread. The multiple thread lengths come in various options which can assist to ensure fit for various bone sizes. General trauma screws are intended for compression and fixation of bone.

This Submission also references Washers and Trays. The Trays are specific to the Tyber Medical Trauma Screws.

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