510(k) K250315
K250315 is an FDA 510(k) premarket notification submitted by AIRS, Inc. for the device "RONAVIS FX (FX-001)". The FDA issued a decision of Substantially Equivalent on August 1, 2025. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2025
- Date Received
- February 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type