FDA 510(k)

Universal Tendon Spacer

Número K: K243477 · 2025-01-10

Data da decisão2025-01-10

Código do produtoHXA

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Universal Tendon Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Askorn Medical. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K243477. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Universal Tendon Spacer?

Universal Tendon Spacer is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Askorn Medical. The 510(k) number is K243477.

When did Universal Tendon Spacer receive FDA 510(k) clearance?

Universal Tendon Spacer received FDA 510(k) clearance on 2025-01-10, under 510(k) number K243477.

Who is the listed applicant for Universal Tendon Spacer?

The FDA 510(k) record lists Askorn Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal Tendon Spacer?

The FDA product code for Universal Tendon Spacer is HXA.

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