Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Other records listing Seaspine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212135Dry DBM- A Putty

Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

Official Source

View on FDA Database →

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

↑