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FDA 510(k)

NUVASIVE SPHERX II SYSTEM

K-Number: K061778 · 2006-07-18

ApplicantNuvasive, Inc.
Decision Date2006-07-18
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE SPHERX II 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 2006-07-18 under 510(k) number K061778. 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 II SYSTEM?

NUVASIVE SPHERX II SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Nuvasive, Inc.. The 510(k) number is K061778.

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

NUVASIVE SPHERX II SYSTEM received FDA 510(k) clearance on 2006-07-18, under 510(k) number K061778.

Who is the listed applicant for NUVASIVE SPHERX II 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 II SYSTEM?

The FDA product code for NUVASIVE SPHERX II SYSTEM is MNH. This falls under the ENT category.

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Other records listing Nuvasive, Inc. 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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