K133398 is an FDA 510(k) clearance for the STRYKER PEDIATRIC MANDIBLE DISTRACTOR. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 20, 2014, 134 days after receiving the submission on November 6, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K133398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2013 |
| Decision Date | March 20, 2014 |
| Days to Decision | 134 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 |