Data / Medical devices / External Mandibular Fixator And/Or Distractor / United States
FDA-registered makers of External Mandibular Fixator And/Or Distractor in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make External Mandibular Fixator And/Or Distractor (product code MQN). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- External Mandibular Fixator And/Or Distractor
- Product code
- MQN
- Country
- United States
Makers of External Mandibular Fixator And/Or Distractor in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 16 | March 13, 2019 | 0 | 1 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 9 | August 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 5 | November 17, 2006 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 2 | February 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Manufacturing, LLC | Jacksonville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quintus, Inc. | Camp Verde, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.