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FDA 510(k)

NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM

K-Number: K053581 · 2006-02-17

ApplicantNuvasive, Inc.
Decision Date2006-02-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE SMARTPLATE GRADIENT PLUS 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 2006-02-17 under 510(k) number K053581. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM?

NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Nuvasive, Inc.. The 510(k) number is K053581.

When did NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM receive FDA 510(k) clearance?

NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM received FDA 510(k) clearance on 2006-02-17, under 510(k) number K053581.

Who is the listed applicant for NUVASIVE SMARTPLATE GRADIENT PLUS 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 SMARTPLATE GRADIENT PLUS SYSTEM?

The FDA product code for NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM is KWQ.

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Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: KWQ)

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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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