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FDA 510(k)

RADIOPAQUE BONE CEMENT

K-Number: K043518 · 2005-05-11

ApplicantCardinalhealth
Decision Date2005-05-11
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RADIOPAQUE BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2005-05-11 under 510(k) number K043518. 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 RADIOPAQUE BONE CEMENT?

RADIOPAQUE BONE CEMENT is a medical device that received FDA 510(k) clearance on 2005-05-11. The listed applicant is Cardinalhealth. The 510(k) number is K043518.

When did RADIOPAQUE BONE CEMENT receive FDA 510(k) clearance?

RADIOPAQUE BONE CEMENT received FDA 510(k) clearance on 2005-05-11, under 510(k) number K043518.

Who is the listed applicant for RADIOPAQUE BONE CEMENT?

The FDA 510(k) record lists Cardinalhealth as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOPAQUE BONE CEMENT?

The FDA product code for 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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