K955640 is an FDA 510(k) clearance for the LORENZ MANDIBULAR DISTRACTOR. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 14, 1996, 64 days after receiving the submission on December 12, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K955640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1995 |
| Decision Date | February 14, 1996 |
| Days to Decision | 64 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 |