(21 days)
Synthes Low Profile Neuro System is 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.
Synthes Ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and Ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.
The provided text describes a 510(k) premarket notification for a medical device (Synthes Low Profile Neuro System - 3 mm Screws) and does not contain information about acceptance criteria, device performance studies, or clinical trial data. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a performance study report.
Therefore, I cannot fulfill your request for the tables and details about acceptance criteria and study design because the necessary information is not present in the provided text. The document primarily focuses on regulatory classification, intended use, and substantial equivalence, without detailing performance metrics or supporting studies with specific data.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.