FDA 510(k)

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

N.º K: K230094 · 2023-08-25

Fecha de decisión2023-08-25

Código de productoMBI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230094. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Responsive Arthroscopy, LLC. The 510(k) number is K230094.

When did Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors receive FDA 510(k) clearance?

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230094.

Who is the listed applicant for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

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

What is the FDA product code for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

The FDA product code for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is MBI.

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Fuente oficial

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