(122 days)
The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).
I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a medical device called "RAPID IMF™", stating that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory compliance requirements. It also includes the indications for use of the device.
§ 872.4600 Intraoral ligature and wire lock.
(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(b)
Classification. Class II.