FDA 510(k)

Fusion FibFix Nail

Número K: K252961 · 2026-03-18

Data da decisão2026-03-18

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the Fusion FibFix Nail?

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

When did Fusion FibFix Nail receive FDA 510(k) clearance?

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

Who is the listed applicant for Fusion FibFix Nail?

The FDA 510(k) record lists Fusion Orthopedics USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion FibFix Nail?

The FDA product code for Fusion FibFix Nail is HSB.

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