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FDA 510(k)

EAUM TOTAL KNEE SYSTEM

K-Number: K110404 · 2012-02-16

ApplicantCorentec Co., Ltd.
Decision Date2012-02-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EAUM TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K110404. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAUM TOTAL KNEE SYSTEM?

EAUM TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K110404.

When did EAUM TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

EAUM TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2012-02-16, under 510(k) number K110404.

Who is the listed applicant for EAUM TOTAL KNEE SYSTEM?

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

What is the FDA product code for EAUM TOTAL KNEE SYSTEM?

The FDA product code for EAUM TOTAL KNEE SYSTEM is JWH.

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Related Devices (Code: JWH)

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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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