K990944 is an FDA 510(k) clearance for the OSTEOMED INTRAORAL DISTRACTION SYSTEM. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on June 16, 1999, 86 days after receiving the submission on March 22, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K990944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1999 |
| Decision Date | June 16, 1999 |
| Days to Decision | 86 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 |