Data / Medical devices / External Mandibular Fixator And/Or Distractor

External Mandibular Fixator And/Or Distractor (MQN): 23 FDA-registered makers in 3 countries

23 establishments in 3 countries are registered with the FDA to make External Mandibular Fixator And/Or Distractor (product code MQN, Class 2, 21 CFR 872.4760). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on August 11, 2022, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

MQN

Device class

2

Regulation

872.4760

Medical specialty

Dental

Implant

Yes

Makers by country

Makers of External Mandibular Fixator And/Or Distractor

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated August 11, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.