K082375 is an FDA 510(k) clearance for the ORTHOPEDIATRICS 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 October 17, 2008, 60 days after receiving the submission on August 18, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K082375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2008 |
| Decision Date | October 17, 2008 |
| Days to Decision | 60 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 |