Submission Details
| 510(k) Number | K183113 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Mar 2019
Decision
124d
Days
Class 2
Risk
About This 510(k) Submission
K183113 is an FDA 510(k) clearance for the DePuy Synthes Maxillofacial Portfolio - MR Conditional, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Synthes USA Products, LLC (19380, 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 review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | MQN — External Mandibular Fixator And/or Distractor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
Manufacturer
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