K250315 is an FDA 510(k) clearance for the RONAVIS – FX (FX-001). This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by AIRS, Inc. (Daegu, KR). The FDA issued a Cleared decision on August 1, 2025, 178 days after receiving the submission on February 4, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K250315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | August 01, 2025 |
| Days to Decision | 178 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 |