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FDA 510(k)

CONCORD Radiopaque Bone Cement

K-Number: K042168 · 2005-01-14

ApplicantGlobus Medical, Inc.
Decision Date2005-01-14
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCORD 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 2005-01-14 under 510(k) number K042168. 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 Radiopaque Bone Cement?

CONCORD Radiopaque Bone Cement is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K042168.

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

CONCORD Radiopaque Bone Cement received FDA 510(k) clearance on 2005-01-14, under 510(k) number K042168.

Who is the listed applicant for CONCORD 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 Radiopaque Bone Cement?

The FDA product code for CONCORD 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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