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FDA 510(k)

OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM

K-Number: K041089 · 2004-08-31

ApplicantBiomet Manufacturing, Inc.
Decision Date2004-08-31
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2004-08-31 under 510(k) number K041089. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM?

OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K041089.

When did OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM receive FDA 510(k) clearance?

OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM received FDA 510(k) clearance on 2004-08-31, under 510(k) number K041089.

Who is the listed applicant for OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM?

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

What is the FDA product code for OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM?

The FDA product code for OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM is MQV.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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