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FDA 510(k)

GENEX BONE GRAFT SUBSTITUTE

K-Number: K040600 · 2004-05-07

ApplicantBiocomposites, Ltd.
Decision Date2004-05-07
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENEX BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2004-05-07 under 510(k) number K040600. 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 GENEX BONE GRAFT SUBSTITUTE?

GENEX BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2004-05-07. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K040600.

When did GENEX BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

GENEX BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2004-05-07, under 510(k) number K040600.

Who is the listed applicant for GENEX BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for GENEX BONE GRAFT SUBSTITUTE?

The FDA product code for GENEX BONE GRAFT SUBSTITUTE is MQV.

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Related Devices (Code: MQV)

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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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