Submission Details
| 510(k) Number | K162594 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Craniomaxillofacial Distraction System (CMFD)
May 2017
Decision
234d
Days
Class 2
Risk
About This 510(k) Submission
K162594 is an FDA 510(k) clearance for the Craniomaxillofacial Distraction System (CMFD), 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 May 8, 2017, 234 days after receiving the submission on September 16, 2016. 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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