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FDA 510(k)

DEPUY CMW 1 GENTAMICIN BONE CEMENT

K-Number: K053002 · 2005-11-22

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

Device Summary

DEPUY CMW 1 GENTAMICIN BONE CEMENT 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 K053002. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY CMW 1 GENTAMICIN BONE CEMENT?

DEPUY CMW 1 GENTAMICIN BONE CEMENT 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 K053002.

When did DEPUY CMW 1 GENTAMICIN BONE CEMENT receive FDA 510(k) clearance?

DEPUY CMW 1 GENTAMICIN BONE CEMENT received FDA 510(k) clearance on 2005-11-22, under 510(k) number K053002.

Who is the listed applicant for DEPUY CMW 1 GENTAMICIN BONE CEMENT?

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 GENTAMICIN BONE CEMENT?

The FDA product code for DEPUY CMW 1 GENTAMICIN BONE CEMENT is MBB.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: MBB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252443SpaceFix Shoulder SpacerG21, S.R.L.K242216GENTAFIX® (1, 3, 3MV)Teknimed SasK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbHK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.

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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