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FDA 510(k)

CALCIGEN -NAP BONE VOID FILLER

K-Number: K033611 · 2004-04-27

ApplicantBiomet, Inc.
Decision Date2004-04-27
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALCIGEN -NAP BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K033611. 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 CALCIGEN -NAP BONE VOID FILLER?

CALCIGEN -NAP BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Biomet, Inc.. The 510(k) number is K033611.

When did CALCIGEN -NAP BONE VOID FILLER receive FDA 510(k) clearance?

CALCIGEN -NAP BONE VOID FILLER received FDA 510(k) clearance on 2004-04-27, under 510(k) number K033611.

Who is the listed applicant for CALCIGEN -NAP BONE VOID FILLER?

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

What is the FDA product code for CALCIGEN -NAP BONE VOID FILLER?

The FDA product code for CALCIGEN -NAP BONE VOID FILLER is MQV.

Related Clinical Trials

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.

Other records listing Biomet, Inc. as applicant

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.

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Related Devices (Code: MQV)

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.

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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