Submission Details
| 510(k) Number | K143285 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2014 |
| Decision Date | May 28, 2015 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Mandible External Fixator - MR Conditional
May 2015
Decision
192d
Days
Class 2
Risk
About This 510(k) Submission
K143285 is an FDA 510(k) clearance for the Mandible External Fixator - MR Conditional, 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 28, 2015, 192 days after receiving the submission on November 17, 2014. 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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