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FDA 510(k)

NorthStar OCT System

K-Number: K231654 · 2023-08-03

ApplicantSeaspine, Inc.
Decision Date2023-08-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the NorthStar OCT System?

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

When was NorthStar OCT System approved by the FDA?

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

What company makes NorthStar OCT System?

NorthStar OCT System is manufactured by Seaspine, Inc..

What is the FDA product code for NorthStar OCT System?

The FDA product code for NorthStar OCT System is NKG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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