(235 days)
The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.
DRG LockJaw™ 15 Minute Intermaxillary Fixation System
This is a scanned FDA letter for a 510k submission for the DRG LockJaw™ 15 Minute Intermaxillary Fixation System. Unfortunately, the letter does not contain the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.).
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls. The letter also includes the stated indications for use of the device.
Therefore, I cannot provide the detailed information you requested based solely on the provided text. To get this information, you would typically need to review the full 510(k) summary or submission documents, which are not included here.
§ 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.