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FDA 510(k)

XPAND CORPECTOMY SPACER

K-Number: K050850 · 2005-05-26

ApplicantGlobus Medical, Inc.
Decision Date2005-05-26
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XPAND CORPECTOMY 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 2005-05-26 under 510(k) number K050850. 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 XPAND CORPECTOMY SPACER?

XPAND CORPECTOMY SPACER is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Globus Medical, Inc.. The 510(k) number is K050850.

When did XPAND CORPECTOMY SPACER receive FDA 510(k) clearance?

XPAND CORPECTOMY SPACER received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050850.

Who is the listed applicant for XPAND CORPECTOMY 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 XPAND CORPECTOMY SPACER?

The FDA product code for XPAND CORPECTOMY SPACER 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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