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FDA 510(k)

COBALT MV BONE CEMENT

K-Number: K091608 · 2009-09-17

ApplicantBiomet Manufacturing Corp
Decision Date2009-09-17
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COBALT MV BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2009-09-17 under 510(k) number K091608. 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 COBALT MV BONE CEMENT?

COBALT MV BONE CEMENT is a medical device that received FDA 510(k) clearance on 2009-09-17. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K091608.

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

COBALT MV BONE CEMENT received FDA 510(k) clearance on 2009-09-17, under 510(k) number K091608.

Who is the listed applicant for COBALT MV BONE CEMENT?

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

What is the FDA product code for COBALT MV BONE CEMENT?

The FDA product code for COBALT MV BONE CEMENT is LOD.

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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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