K181504 is an FDA 510(k) clearance for the Stryker Pediatric Mandibular Distractor 2. 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 September 11, 2018, 96 days after receiving the submission on June 7, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K181504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2018 |
| Decision Date | September 11, 2018 |
| Days to Decision | 96 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 |