K034027 is an FDA 510(k) clearance for the KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 27, 2004, 60 days after receiving the submission on December 29, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K034027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2003 |
| Decision Date | February 27, 2004 |
| Days to Decision | 60 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 |