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FDA 510(k)

CONCORD Plus Radiopaque Bone Cement

K-Number: K162618 · 2017-01-23

ApplicantGlobus Medical, Inc.
Decision Date2017-01-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCORD Plus Radiopaque Bone Cement is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-01-23 under approval number K162618. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCORD Plus Radiopaque Bone Cement?

CONCORD Plus Radiopaque Bone Cement is a medical device that received FDA 510(k) clearance on 2017-01-23. It is manufactured by Globus Medical, Inc.. The 510(k) number is K162618.

When was CONCORD Plus Radiopaque Bone Cement approved by the FDA?

CONCORD Plus Radiopaque Bone Cement received FDA 510(k) clearance on 2017-01-23, under approval number K162618.

What company makes CONCORD Plus Radiopaque Bone Cement?

CONCORD Plus Radiopaque Bone Cement is manufactured by Globus Medical, Inc..

What is the FDA product code for CONCORD Plus Radiopaque Bone Cement?

The FDA product code for CONCORD Plus Radiopaque Bone Cement is NDN.

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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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