Freedom Nail Ankle Fusion System— 510(k) K261189
Substantially EquivalentMcGinley Orthopaedic Innovations
FDA 510(k) clearance K261189 for Freedom Nail Ankle Fusion System, Substantially Equivalent on 2026-10-19. Applicant: McGinley Orthopaedic Innovations. Device class: 2.
Clearance details
- Applicant
- McGinley Orthopaedic Innovations
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Casper, WY, US
Recent devices under product code HSB
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.