FDA 510(k)

Integrity™ Bone Staple Fixation System

Número K: K223860 · 2023-05-22

Data da decisão2023-05-22

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Integrity™ Bone Staple Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K223860. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Integrity™ Bone Staple Fixation System?

Integrity™ Bone Staple Fixation System is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K223860.

When did Integrity™ Bone Staple Fixation System receive FDA 510(k) clearance?

Integrity™ Bone Staple Fixation System received FDA 510(k) clearance on 2023-05-22, under 510(k) number K223860.

Who is the listed applicant for Integrity™ Bone Staple Fixation System?

The FDA 510(k) record lists Anika Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integrity™ Bone Staple Fixation System?

The FDA product code for Integrity™ Bone Staple Fixation System is MBI.

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Outros registros que listam Anika Therapeutics, Inc. como candidato(a)

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Fonte oficial

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