(451 days)
Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.
Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers,etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.)
This section is not applicable, as it is a 510(k) premarket notification for a medical device (bone fixation fastener, ligature, and wire lock) and does not involve AI/ML device performance studies. The document describes the FDA's clearance of the device for market based on substantial equivalence, rather than detailing a study against acceptance criteria.
§ 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.