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FDA 510(k)

NUVASIVE NVM5 SYSTEM

K-Number: K112718 · 2012-03-16

ApplicantNuvasive, Inc.
Decision Date2012-03-16
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NUVASIVE NVM5 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K112718. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE NVM5 SYSTEM?

NUVASIVE NVM5 SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Nuvasive, Inc.. The 510(k) number is K112718.

When did NUVASIVE NVM5 SYSTEM receive FDA 510(k) clearance?

NUVASIVE NVM5 SYSTEM received FDA 510(k) clearance on 2012-03-16, under 510(k) number K112718.

Who is the listed applicant for NUVASIVE NVM5 SYSTEM?

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

What is the FDA product code for NUVASIVE NVM5 SYSTEM?

The FDA product code for NUVASIVE NVM5 SYSTEM is ETN.

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Related Devices (Code: ETN)

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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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