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Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System devices (Plates, Meshes, Sheets and Screws) are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets and Screws may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System consists of Plates, Meshes, Sheets and Screws. The system is provided in a variety of shapes and sizes and, when used in conjunction with resorbable screws, the system provides fixation and aids in the alignment and stabilization of craniofacial bones. To facilitate shaping to the contours of the anatomy, the thermoplastic implants may be heated above the glass transition temperature of 55° C or they may be cut to the desired shape.

This 510(k) summary describes a resorbable fixation system and does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it is not a medical device that processes or analyzes data. Therefore, the requested information cannot be extracted from the provided text.

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