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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-01-23 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K162618.

When did CONCORD Plus Radiopaque Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for CONCORD Plus Radiopaque Bone Cement?

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 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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