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FDA 510(k)

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS

K-Number: K112756 · 2011-10-07

ApplicantGlobus Medical, Inc.
Decision Date2011-10-07
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY 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 2011-10-07 under 510(k) number K112756. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS?

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Globus Medical, Inc.. The 510(k) number is K112756.

When did FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS receive FDA 510(k) clearance?

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS received FDA 510(k) clearance on 2011-10-07, under 510(k) number K112756.

Who is the listed applicant for FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY 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 FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS?

The FDA product code for FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS is MQP.

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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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