FDA product code MQN: External Mandibular Fixator And/Or Distractor
MQN is the FDA product code for external mandibular fixator and/or distractor. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel. FDA has cleared 60 510(k) submissions under MQN, 1 in the last five years, from 23 different applicants. The average 510(k) review took 119 days (median 87). FDA has posted 9 recalls for MQN devices.
Classification
| Field | Value |
|---|---|
| Device name | External Mandibular Fixator And/Or Distractor |
| Device class | Class II |
| Regulation | 21 CFR 872.4760 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MQN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 234 |
| 2018 | 1 | 96 |
| 2019 | 1 | 124 |
| 2022 | 1 | 217 |
Compare with all 510(k) review times · Search every MQN clearance
Top MQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 12 | 2008-05-14 |
| KLS-Martin L.P. | 10 | 2004-02-27 |
| Walter Lorenz Surgical, Inc. | 6 | 2003-06-17 |
| Osteomed LP | 5 | 2007-03-02 |
| KLS Martin L.P. | 3 | 2022-08-11 |
18 more applicants have MQN clearances. See the full list in Caduvo.
Most recent MQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220050 | KLS Martin L.P. | KLS Martin IPS Distraction | 2022-08-11 | 217 |
| K183113 | Synthes (USA) Products, LLC | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019-03-13 | 124 |
| K181504 | Stryker | Stryker Pediatric Mandibular Distractor 2 | 2018-09-11 | 96 |
| K162594 | Synthes USA Products, LLC | Craniomaxillofacial Distraction System (CMFD) | 2017-05-08 | 234 |
| K161470 | KLS Martin L.P. | Internal Distraction - Sterile | 2016-12-01 | 188 |
Recalls for MQN devices
9 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-05-23.
Frequently asked questions
What is FDA product code MQN?
MQN is the FDA product code for external mandibular fixator and/or distractor. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel.
What device class is MQN?
Class II, regulation 21 CFR 872.4760. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQN?
Across 60 cleared submissions the average was 119 days from receipt to decision (median 87).
Which companies have the most MQN clearances?
Synthes (Usa) (12); KLS-Martin L.P. (10); Walter Lorenz Surgical, Inc. (6); Osteomed LP (5); KLS Martin L.P. (3).
Have MQN devices been recalled?
Yes: 9 product recalls across 4 recall events; the most recent began 2016-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MQN
- Run a recall and safety report across every MQN manufacturer
- Watch product code MQN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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