K183113 is an FDA 510(k) clearance for the DePuy Synthes Maxillofacial Portfolio - MR Conditional. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on March 13, 2019, 124 days after receiving the submission on November 9, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K183113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2018 |
| Decision Date | March 13, 2019 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQN — External Mandibular Fixator And/or Distractor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |