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FDA 510(k)

COALITION Spacers

K-Number: K151939 · 2016-01-29

ApplicantGlobus Medical, Inc.
Decision Date2016-01-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COALITION 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 2016-01-29 under 510(k) number K151939. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COALITION Spacers?

COALITION Spacers is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Globus Medical, Inc.. The 510(k) number is K151939.

When did COALITION Spacers receive FDA 510(k) clearance?

COALITION Spacers received FDA 510(k) clearance on 2016-01-29, under 510(k) number K151939.

Who is the listed applicant for COALITION 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 COALITION Spacers?

The FDA product code for COALITION Spacers is OVE.

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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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