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CONCORD Radiopaque Bone Cement

by Globus Medical, Inc.

510(k) K042168

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042168 Date14 Jan 2005ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NDN
Device class
Class II
Regulation
21 CFR Part 888.3027
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CONCORD Radiopaque Bone Cement is a radiopaque, self-curing, PMMA bone cement provided as a two-component system consisting of a liquid component and a powder component that are mixed together prior to use. It is designed for use in orthopedic procedures as a high-viscosity cement.

The device is supplied sterile and is intended for single use. It is classified under product code NDN and has received FDA 510(k) clearance with the number K042168. The cement is manufactured by Globus Medical, Inc. and is used in various orthopedic applications including vertebroplasty.

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