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FDA 510(k)

NuVaisve® Reline® Cervical System

K-Number: K191553 · 2019-08-14

ApplicantNu Vasive, Incorporated
Decision Date2019-08-14
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVaisve® Reline® Cervical 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 2019-08-14 under 510(k) number K191553. 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 NuVaisve® Reline® Cervical System?

NuVaisve® Reline® Cervical System is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K191553.

When did NuVaisve® Reline® Cervical System receive FDA 510(k) clearance?

NuVaisve® Reline® Cervical System received FDA 510(k) clearance on 2019-08-14, under 510(k) number K191553.

Who is the listed applicant for NuVaisve® Reline® Cervical 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 NuVaisve® Reline® Cervical System?

The FDA product code for NuVaisve® Reline® Cervical 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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