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FDA 510(k)

NuVasive Next Generation NVM5 System

K-Number: K162313 · 2017-03-16

ApplicantNu Vasive, Incorporated
Decision Date2017-03-16
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NuVasive Next Generation NVM5 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 2017-03-16 under 510(k) number K162313. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive Next Generation NVM5 System?

NuVasive Next Generation NVM5 System is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K162313.

When did NuVasive Next Generation NVM5 System receive FDA 510(k) clearance?

NuVasive Next Generation NVM5 System received FDA 510(k) clearance on 2017-03-16, under 510(k) number K162313.

Who is the listed applicant for NuVasive Next Generation NVM5 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 NuVasive Next Generation NVM5 System?

The FDA product code for NuVasive Next Generation NVM5 System is PDQ.

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: PDQ)

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.

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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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