FDA 510(k)

Ancrage avec fil en fibres et inserteur jetable

Numéro K : K253027 · 2026-05-06

Date de décision2026-05-06

Code produitMBI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : MBI)

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Source officielle

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