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FDA 510(k)

VuePoint OCT System

K-Number: K153336 · 2016-01-07

ApplicantNu Vasive, Incorporated
Decision Date2016-01-07
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VuePoint OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153336. 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 VuePoint OCT System?

VuePoint OCT System is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K153336.

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

VuePoint OCT System received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153336.

Who is the listed applicant for VuePoint OCT System?

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

What is the FDA product code for VuePoint OCT System?

The FDA product code for VuePoint OCT System is NKG.

Other records listing Nu Vasive, Incorporated 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.

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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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.

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