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FDA 510(k)

NUVASIVE SPHERX SYSTEM

K-Number: K060225 · 2006-04-12

ApplicantNuvasive, Inc.
Decision Date2006-04-12
Product CodeMNH
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 2006-04-12 under 510(k) number K060225. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. 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 2006-04-12. The listed applicant is Nuvasive, Inc.. The 510(k) number is K060225.

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

NUVASIVE SPHERX SYSTEM received FDA 510(k) clearance on 2006-04-12, under 510(k) number K060225.

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 MNH. This falls under the ENT category.

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Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: MNH)

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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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