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FDA 510(k)

EOVIA CALCIUM PHOSPHATE CERAMIC

K-Number: K040514 · 2004-05-03

ApplicantOrtho Tec, LLC
Decision Date2004-05-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EOVIA CALCIUM PHOSPHATE CERAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2004-05-03 under 510(k) number K040514. 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 EOVIA CALCIUM PHOSPHATE CERAMIC?

EOVIA CALCIUM PHOSPHATE CERAMIC is a medical device that received FDA 510(k) clearance on 2004-05-03. The listed applicant is Ortho Tec, LLC. The 510(k) number is K040514.

When did EOVIA CALCIUM PHOSPHATE CERAMIC receive FDA 510(k) clearance?

EOVIA CALCIUM PHOSPHATE CERAMIC received FDA 510(k) clearance on 2004-05-03, under 510(k) number K040514.

Who is the listed applicant for EOVIA CALCIUM PHOSPHATE CERAMIC?

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

What is the FDA product code for EOVIA CALCIUM PHOSPHATE CERAMIC?

The FDA product code for EOVIA CALCIUM PHOSPHATE CERAMIC is 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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