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FDA 510(k)

NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE

K-Number: K041613 · 2004-08-25

ApplicantNovabone Products, LLC
Decision Date2004-08-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2004-08-25 under 510(k) number K041613. 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 NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE?

NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Novabone Products, LLC. The 510(k) number is K041613.

When did NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2004-08-25, under 510(k) number K041613.

Who is the listed applicant for NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE?

The FDA product code for NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE 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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