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FDA 510(k)

PROTEX STABILIZATION SYSTEM

K-Number: K040442 · 2004-05-20

ApplicantGlobus Medical, Inc.
Decision Date2004-05-20
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROTEX STABILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K040442. 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 PROTEX STABILIZATION SYSTEM?

PROTEX STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K040442.

When did PROTEX STABILIZATION SYSTEM receive FDA 510(k) clearance?

PROTEX STABILIZATION SYSTEM received FDA 510(k) clearance on 2004-05-20, under 510(k) number K040442.

Who is the listed applicant for PROTEX STABILIZATION SYSTEM?

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

What is the FDA product code for PROTEX STABILIZATION SYSTEM?

The FDA product code for PROTEX STABILIZATION SYSTEM is MNH. This falls under the ENT category.

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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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