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FDA 510(k)

PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES

K-Number: K052069 · 2005-08-17

ApplicantGlobus Medical, Inc.
Decision Date2005-08-17
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES 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 2005-08-17 under 510(k) number K052069. 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 STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES?

PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES is a medical device that received FDA 510(k) clearance on 2005-08-17. The listed applicant is Globus Medical, Inc.. The 510(k) number is K052069.

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

PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES received FDA 510(k) clearance on 2005-08-17, under 510(k) number K052069.

Who is the listed applicant for PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES?

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 WITH ADDITIONAL COMPONENTES?

The FDA product code for PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES 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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