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FDA 510(k)

PROTEX CT CERVICOTHORACIC SPINAL SYSTEM

K-Number: K081906 · 2008-11-14

ApplicantGlobus Medical, Inc.
Decision Date2008-11-14
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROTEX CT CERVICOTHORACIC SPINAL 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 2008-11-14 under 510(k) number K081906. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEX CT CERVICOTHORACIC SPINAL SYSTEM?

PROTEX CT CERVICOTHORACIC SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K081906.

When did PROTEX CT CERVICOTHORACIC SPINAL SYSTEM receive FDA 510(k) clearance?

PROTEX CT CERVICOTHORACIC SPINAL SYSTEM received FDA 510(k) clearance on 2008-11-14, under 510(k) number K081906.

Who is the listed applicant for PROTEX CT CERVICOTHORACIC SPINAL 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 CT CERVICOTHORACIC SPINAL SYSTEM?

The FDA product code for PROTEX CT CERVICOTHORACIC SPINAL SYSTEM is KWP.

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Related Devices (Code: KWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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