FDA 510(k)

PATRIOT TRANSCONTINENTAL M SPACERS

K-Number: K102313 · 2010-12-03

Decision Date2010-12-03

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PATRIOT TRANSCONTINENTAL M 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 2010-12-03 under 510(k) number K102313. 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 M SPACERS?

PATRIOT TRANSCONTINENTAL M SPACERS is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Globus Medical, Inc.. The 510(k) number is K102313.

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

PATRIOT TRANSCONTINENTAL M SPACERS received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102313.

Who is the listed applicant for PATRIOT TRANSCONTINENTAL M 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 TRANSCONTINENTAL M SPACERS?

The FDA product code for PATRIOT TRANSCONTINENTAL M 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.