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FDA 510(k)

COLOSSEUM Mesh

K-Number: K190147 · 2019-05-08

ApplicantGlobus Medical, Inc.
Decision Date2019-05-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLOSSEUM Mesh is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-05-08 under approval number K190147. 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 COLOSSEUM Mesh?

COLOSSEUM Mesh is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Globus Medical, Inc.. The 510(k) number is K190147.

When was COLOSSEUM Mesh approved by the FDA?

COLOSSEUM Mesh received FDA 510(k) clearance on 2019-05-08, under approval number K190147.

What company makes COLOSSEUM Mesh?

COLOSSEUM Mesh is manufactured by Globus Medical, Inc..

What is the FDA product code for COLOSSEUM Mesh?

The FDA product code for COLOSSEUM Mesh is MQP.

Other Devices by Globus Medical, Inc.

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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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