FDA 510(k)

PATRIOT TRANSCONTINENTAL LLIF SPACER

K-Number: K093242 · 2009-12-23

Decision Date2009-12-23

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PATRIOT TRANSCONTINENTAL LLIF SPACER 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 2009-12-23 under 510(k) number K093242. 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 TRANSCONTINENTAL LLIF SPACER?

PATRIOT TRANSCONTINENTAL LLIF SPACER is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Globus Medical, Inc.. The 510(k) number is K093242.

When did PATRIOT TRANSCONTINENTAL LLIF SPACER receive FDA 510(k) clearance?

PATRIOT TRANSCONTINENTAL LLIF SPACER received FDA 510(k) clearance on 2009-12-23, under 510(k) number K093242.

Who is the listed applicant for PATRIOT TRANSCONTINENTAL LLIF SPACER?

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 TRANSCONTINENTAL LLIF SPACER?

The FDA product code for PATRIOT TRANSCONTINENTAL LLIF SPACER 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.