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FDA 510(k)

DEPUY CMW 1, 2 AND 3 BONE CEMENTS

K-Number: K053003 · 2005-11-22

ApplicantDePuy Orthopaedics, Inc.
Decision Date2005-11-22
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY CMW 1, 2 AND 3 BONE CEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2005-11-22 under 510(k) number K053003. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY CMW 1, 2 AND 3 BONE CEMENTS?

DEPUY CMW 1, 2 AND 3 BONE CEMENTS is a medical device that received FDA 510(k) clearance on 2005-11-22. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K053003.

When did DEPUY CMW 1, 2 AND 3 BONE CEMENTS receive FDA 510(k) clearance?

DEPUY CMW 1, 2 AND 3 BONE CEMENTS received FDA 510(k) clearance on 2005-11-22, under 510(k) number K053003.

Who is the listed applicant for DEPUY CMW 1, 2 AND 3 BONE CEMENTS?

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

What is the FDA product code for DEPUY CMW 1, 2 AND 3 BONE CEMENTS?

The FDA product code for DEPUY CMW 1, 2 AND 3 BONE CEMENTS is LOD.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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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