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FDA 510(k)

CAP3 BONE SUBSTITUTE MATERIAL

K-Number: K033138 · 2003-12-02

ApplicantEtex Corp.
Decision Date2003-12-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAP3 BONE SUBSTITUTE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2003-12-02 under 510(k) number K033138. 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 CAP3 BONE SUBSTITUTE MATERIAL?

CAP3 BONE SUBSTITUTE MATERIAL is a medical device that received FDA 510(k) clearance on 2003-12-02. The listed applicant is Etex Corp.. The 510(k) number is K033138.

When did CAP3 BONE SUBSTITUTE MATERIAL receive FDA 510(k) clearance?

CAP3 BONE SUBSTITUTE MATERIAL received FDA 510(k) clearance on 2003-12-02, under 510(k) number K033138.

Who is the listed applicant for CAP3 BONE SUBSTITUTE MATERIAL?

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

What is the FDA product code for CAP3 BONE SUBSTITUTE MATERIAL?

The FDA product code for CAP3 BONE SUBSTITUTE MATERIAL is MQV.

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Other records listing Etex Corp. as applicant

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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.

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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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