Submission Details
| 510(k) Number | K220050 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2022 |
| Decision Date | August 11, 2022 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
KLS Martin IPS Distraction
Aug 2022
Decision
217d
Days
Class 2
Risk
About This 510(k) Submission
K220050 is an FDA 510(k) clearance for the KLS Martin IPS Distraction, 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 August 11, 2022, 217 days after receiving the submission on January 6, 2022. 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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