(20 days)
The Synthes 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes 1.3 & 1.5mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and for single use only.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The text is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.3 & 1.5mm Contourable Titanium Mesh Plates). This type of document primarily focuses on establishing substantial equivalence to a predicate device, not on specific performance acceptance criteria or detailed study results demonstrating the device meets those criteria.
Therefore, I cannot provide a response to your request as the information is not present in the given document.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.