FDA 510(k)

Ancora com Fio de Fibra e Inseridor Descartável

Número K: K253027 · 2026-05-06

Data da decisão2026-05-06

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anchor with Fiber Wire and Disposable Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Ortobio S.A.. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K253027. 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 Anchor with Fiber Wire and Disposable Inserter?

Anchor with Fiber Wire and Disposable Inserter is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Ortobio S.A.. The 510(k) number is K253027.

When did Anchor with Fiber Wire and Disposable Inserter receive FDA 510(k) clearance?

Anchor with Fiber Wire and Disposable Inserter received FDA 510(k) clearance on 2026-05-06, under 510(k) number K253027.

Who is the listed applicant for Anchor with Fiber Wire and Disposable Inserter?

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

What is the FDA product code for Anchor with Fiber Wire and Disposable Inserter?

The FDA product code for Anchor with Fiber Wire and Disposable Inserter is MBI.

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Fonte oficial

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