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FDA 510(k)

NUVASIVE SPHERX SYSTEM

K-Number: K082332 · 2008-10-10

ApplicantNuvasive, Inc.
Decision Date2008-10-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE SPHERX 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 2008-10-10 under 510(k) number K082332. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE SPHERX SYSTEM?

NUVASIVE SPHERX SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Nuvasive, Inc.. The 510(k) number is K082332.

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

NUVASIVE SPHERX SYSTEM received FDA 510(k) clearance on 2008-10-10, under 510(k) number K082332.

Who is the listed applicant for NUVASIVE SPHERX 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 SPHERX SYSTEM?

The FDA product code for NUVASIVE SPHERX SYSTEM is NKB.

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Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: NKB)

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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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