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FDA 510(k)

NuVasive NuvaLine Mobile App

K-Number: K162647 · 2017-05-01

ApplicantNu Vasive, Incorporated
Decision Date2017-05-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NuVasive NuvaLine Mobile App 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 2017-05-01 under 510(k) number K162647. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive NuvaLine Mobile App?

NuVasive NuvaLine Mobile App is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K162647.

When did NuVasive NuvaLine Mobile App receive FDA 510(k) clearance?

NuVasive NuvaLine Mobile App received FDA 510(k) clearance on 2017-05-01, under 510(k) number K162647.

Who is the listed applicant for NuVasive NuvaLine Mobile App?

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 NuvaLine Mobile App?

The FDA product code for NuVasive NuvaLine Mobile App is LLZ.

Other records listing Nu Vasive, Incorporated as applicant

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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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