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FDA 510(k)

MONUMENT SPACERS

K-Number: K132559 · 2013-12-30

ApplicantGlobus Medical, Inc.
Decision Date2013-12-30
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONUMENT 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 2013-12-30 under 510(k) number K132559. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONUMENT SPACERS?

MONUMENT SPACERS is a medical device that received FDA 510(k) clearance on 2013-12-30. The listed applicant is Globus Medical, Inc.. The 510(k) number is K132559.

When did MONUMENT SPACERS receive FDA 510(k) clearance?

MONUMENT SPACERS received FDA 510(k) clearance on 2013-12-30, under 510(k) number K132559.

Who is the listed applicant for MONUMENT 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 MONUMENT SPACERS?

The FDA product code for MONUMENT SPACERS is OVD.

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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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