K220809 is an FDA 510(k) clearance for the Drive Rail System. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on April 8, 2022, 18 days after receiving the submission on March 21, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K220809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2022 |
| Decision Date | April 08, 2022 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |