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FDA 510(k)

EVOLIS TOTAL KNEE SYSTEM

K-Number: K081023 · 2008-10-22

ApplicantMedacta International S.A.
Decision Date2008-10-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLIS TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2008-10-22 under 510(k) number K081023. 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 EVOLIS TOTAL KNEE SYSTEM?

EVOLIS TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-22. The listed applicant is Medacta International S.A.. The 510(k) number is K081023.

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

EVOLIS TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2008-10-22, under 510(k) number K081023.

Who is the listed applicant for EVOLIS TOTAL KNEE SYSTEM?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: JWH)

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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