FDA 510(k)

NorthStar OCT System

N.º K: K231654 · 2023-08-03

Fecha de decisión2023-08-03

Código de productoNKG

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NorthStar OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K231654. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NorthStar OCT System?

NorthStar OCT System is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Seaspine, Inc.. The 510(k) number is K231654.

When did NorthStar OCT System receive FDA 510(k) clearance?

NorthStar OCT System received FDA 510(k) clearance on 2023-08-03, under 510(k) number K231654.

Who is the listed applicant for NorthStar OCT System?

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

What is the FDA product code for NorthStar OCT System?

The FDA product code for NorthStar OCT System is NKG.

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Fuente oficial

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