K201838 is an FDA 510(k) clearance for the PediFlex Flexible Nail System. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on January 29, 2021, 211 days after receiving the submission on July 2, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K201838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |