FDA 510(k)

Mariner RDX System

N.º K: K222110 · 2022-09-07

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2022-09-07

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Mariner RDX System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K222110. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mariner RDX System?

Mariner RDX System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K222110.

When did Mariner RDX System receive FDA 510(k) clearance?

Mariner RDX System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K222110.

Who is the listed applicant for Mariner RDX System?

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

What is the FDA product code for Mariner RDX System?

The FDA product code for Mariner RDX System is NKB.

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Fuente oficial

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