FDA 510(k)

BONE CEMENT FOR CRANIOPLASTY

K-Number: K040152 · 2004-05-19

Decision Date2004-05-19

Product CodeGXP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BONE CEMENT FOR CRANIOPLASTY is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2004-05-19 under 510(k) number K040152. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE CEMENT FOR CRANIOPLASTY?

BONE CEMENT FOR CRANIOPLASTY is a medical device that received FDA 510(k) clearance on 2004-05-19. The listed applicant is Cardinalhealth. The 510(k) number is K040152.

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

BONE CEMENT FOR CRANIOPLASTY received FDA 510(k) clearance on 2004-05-19, under 510(k) number K040152.

Who is the listed applicant for BONE CEMENT FOR CRANIOPLASTY?

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 BONE CEMENT FOR CRANIOPLASTY?

The FDA product code for BONE CEMENT FOR CRANIOPLASTY is GXP.

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Related Devices (Code: GXP)

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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.