FDA 510(k)

V-STRUT Vertebral Implant

N.º K: K191709 · 2020-03-05

Fecha de decisión2020-03-05

Código de productoNDN

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

V-STRUT Vertebral Implant is the device name listed in this FDA 510(k) record. The listed applicant is Hyprevention Sas. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K191709. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the V-STRUT Vertebral Implant?

V-STRUT Vertebral Implant is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Hyprevention Sas. The 510(k) number is K191709.

When did V-STRUT Vertebral Implant receive FDA 510(k) clearance?

V-STRUT Vertebral Implant received FDA 510(k) clearance on 2020-03-05, under 510(k) number K191709.

Who is the listed applicant for V-STRUT Vertebral Implant?

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

What is the FDA product code for V-STRUT Vertebral Implant?

The FDA product code for V-STRUT Vertebral Implant is NDN.

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Fuente oficial

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