Search Results

The Bioplate Mandible Fixation System is intended for use in the treatment of the facial skeleton and mandible, including fractures and reconstruction. The Bioplate Mandible Fixation System is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Modified Plate and Screw designs for use in conjunction with The Bioplate Mandible Fixation System.

I'm sorry, but this document does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a medical device called "The Bioplate Mandible Fixation System."

This letter primarily focuses on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device as Class II, subject to general controls and potentially additional special controls.
• Indications for Use: Briefly describing the intended use of the device in treating fractures and non-unions of the facial skeleton and mandible.
• Compliance Requirements: Reminding the applicant of various FDA regulations and requirements.

It does not present any specific performance metrics, acceptance criteria, or details of a study that would demonstrate the device's performance against such criteria.

Ask a specific question about this device