K051946 is an FDA 510(k) clearance for the MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by Medartis, Inc. (San Diego, US). The FDA issued a Cleared decision on August 22, 2005, 35 days after receiving the submission on July 18, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K051946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2005 |
| Decision Date | August 22, 2005 |
| Days to Decision | 35 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 |