DeviceClearance

Product code MQN— Dental

SYNTHES MANDIBLE EXTERNAL FIXATOR

Classification name
External Mandibular Fixator And/Or Distractor
Device class
Class 2
Regulation
21 CFR 872.4760
Advisory panel
Dental
Total cleared
60
First cleared
Most recent

Market context for product code MQN

FDA has cleared 60 devices under product code MQN between 1995 and 2022, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MQN

Adverse events under product code MQN

product code MQN
Injury
346
Total
346

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MQN

Data sourced from openFDA. This site is unofficial and independent of the FDA.