FDA 510(k)

NorthStar OCT System

Número K: K231654 · 2023-08-03

Data da decisão2023-08-03

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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