510(k) K261189
K261189 is an FDA 510(k) premarket notification submitted by McGinley Orthopaedic Innovations for the device "Freedom Nail Ankle Fusion System". The FDA issued a decision of Substantially Equivalent on Oct 19, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2026
- Date Received
- Apr 10, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type
- 510(k)