K162594 is an FDA 510(k) clearance for the Craniomaxillofacial Distraction System (CMFD). 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 May 8, 2017, 234 days after receiving the submission on September 16, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K162594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2016 |
| Decision Date | May 08, 2017 |
| Days to Decision | 234 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 |