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FDA 510(k)

PATRIOT SPACERS

K-Number: K122097 · 2012-12-06

ApplicantGlobus Medical, Inc.
Decision Date2012-12-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATRIOT SPACERS 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 2012-12-06 under 510(k) number K122097. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATRIOT SPACERS?

PATRIOT SPACERS is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K122097.

When did PATRIOT SPACERS receive FDA 510(k) clearance?

PATRIOT SPACERS received FDA 510(k) clearance on 2012-12-06, under 510(k) number K122097.

Who is the listed applicant for PATRIOT SPACERS?

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 PATRIOT SPACERS?

The FDA product code for PATRIOT SPACERS is MAX.

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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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