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FDA 510(k)

THE NUFFIELD TOTAL KNEE SYSTEM

K-Number: K980545 · 1998-04-29

ApplicantCorin USA
Decision Date1998-04-29
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE NUFFIELD TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 1998-04-29 under 510(k) number K980545. 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 THE NUFFIELD TOTAL KNEE SYSTEM?

THE NUFFIELD TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Corin USA. The 510(k) number is K980545.

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

THE NUFFIELD TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1998-04-29, under 510(k) number K980545.

Who is the listed applicant for THE NUFFIELD TOTAL KNEE SYSTEM?

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

What is the FDA product code for THE NUFFIELD TOTAL KNEE SYSTEM?

The FDA product code for THE NUFFIELD TOTAL KNEE SYSTEM is 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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