Fusion FibFix Nail— 510(k) K252961
Substantially EquivalentFusion Orthopedics USA, LLC
FDA 510(k) clearance K252961 for Fusion FibFix Nail, Substantially Equivalent on 2026-03-18. Applicant: Fusion Orthopedics USA, LLC. Device class: 2.
Summary
Fusion Orthopedics USA's Fusion FibFix Nail is filed under HSB, intramedullary fixation rods and accessories. The record doesn't list nail lengths or diameters.
Class II, 21 CFR 888.3020. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Fusion Orthopedics USA filed from Mesa, Arizona. The decision came 183 calendar days after FDA received it (September 16, 2025 to March 18, 2026).
Clearance details
- Applicant
- Fusion Orthopedics USA, LLC
- 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
- Mesa, AZ, 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.