Search Results

Synthes Mini External Fixator stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects.

Not Found

The provided text is a 510(k) premarket notification and does not contain information about acceptance criteria or a study proving device performance as typically seen in a clinical study report.

The document is a letter from the FDA to Synthes (USA) confirming that their "Synthes (USA) Mini External Fixator" device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory classification and general controls provisions of the Medical Device Amendments.

The "Indications For Use" section lists the conditions for which the device is intended: "stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided document. This type of information would typically be found in a separate clinical study report or a detailed technical submission, not in the FDA's 510(k) clearance letter itself.

Ask a specific question about this device