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FDA 510(k)

Fusion FibFix Nail

K-Number: K252961 · 2026-03-18

ApplicantFusion Orthopedics USA, LLC
Decision Date2026-03-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fusion FibFix Nail is a medical device manufactured by Fusion Orthopedics USA, LLC. It received FDA 510(k) clearance on 2026-03-18 under approval number K252961. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion FibFix Nail?

Fusion FibFix Nail is a medical device that received FDA 510(k) clearance on 2026-03-18. It is manufactured by Fusion Orthopedics USA, LLC. The 510(k) number is K252961.

When was Fusion FibFix Nail approved by the FDA?

Fusion FibFix Nail received FDA 510(k) clearance on 2026-03-18, under approval number K252961.

What company makes Fusion FibFix Nail?

Fusion FibFix Nail is manufactured by Fusion Orthopedics USA, LLC.

What is the FDA product code for Fusion FibFix Nail?

The FDA product code for Fusion FibFix Nail is HSB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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