Submission Details
| 510(k) Number | K161470 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 2016 |
| Decision Date | December 01, 2016 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Internal Distraction - Sterile
Dec 2016
Decision
188d
Days
Class 2
Risk
About This 510(k) Submission
K161470 is an FDA 510(k) clearance for the Internal Distraction - Sterile, 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 December 1, 2016, 188 days after receiving the submission on May 27, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | MQN — External Mandibular Fixator And/or Distractor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
Manufacturer
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