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FDA 510(k)

XPAND RADIOLUCENT CORPECTOMY SPACER

K-Number: K060665 · 2006-05-10

ApplicantGlobus Medical, Inc.
Decision Date2006-05-10
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XPAND RADIOLUCENT 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 2006-05-10 under 510(k) number K060665. 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 RADIOLUCENT CORPECTOMY SPACER?

XPAND RADIOLUCENT CORPECTOMY SPACER is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Globus Medical, Inc.. The 510(k) number is K060665.

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

XPAND RADIOLUCENT CORPECTOMY SPACER received FDA 510(k) clearance on 2006-05-10, under 510(k) number K060665.

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

The FDA product code for XPAND RADIOLUCENT 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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