MQN — External Mandibular Fixator And/Or Distractor Class II
FDA product code MQN covers "External Mandibular Fixator And/Or Distractor", a Class II medical device regulated under 21 CFR 872.4760. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQN
- Device Class
- Class II
- Regulation Number
- 872.4760
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220050 | kls martin l.p | KLS Martin IPS Distraction | August 11, 2022 |
| K183113 | synthes (usa) products | DePuy Synthes Maxillofacial Portfolio - MR Conditional | March 13, 2019 |
| K181504 | stryker | Stryker Pediatric Mandibular Distractor 2 | September 11, 2018 |
| K162594 | synthes usa products | Craniomaxillofacial Distraction System (CMFD) | May 8, 2017 |
| K161470 | kls martin l.p | Internal Distraction - Sterile | December 1, 2016 |
| K143285 | synthes usa products | Mandible External Fixator - MR Conditional | May 28, 2015 |
| K133398 | stryker | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | March 20, 2014 |
| K121502 | synthes | SYNTHES CURVILINEAR DISTRACTION SYSTEM | August 23, 2012 |
| K080458 | mis - implant technologies | MIS CREST WIDENER | December 17, 2008 |
| K080542 | john w. king | DISTRAX | December 15, 2008 |
| K080153 | synthes (usa) | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | May 14, 2008 |
| K072764 | kls martin l.p | KLS MARTIN XTERNAL FIXATOR | December 20, 2007 |
| K071628 | stryker cmf | STRYKER EXTERNAL FIXATION SYSTEM | August 10, 2007 |
| K062572 | custom scientific | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | May 11, 2007 |
| K063792 | osteomed | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | March 2, 2007 |
| K062851 | osteomed | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | November 17, 2006 |
| K062299 | synthes (usa) | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | August 31, 2006 |
| K060138 | synthes (usa) | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | June 2, 2006 |
| K051946 | medartis | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | August 22, 2005 |
| K043555 | synthes (usa) | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | April 12, 2005 |