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FDA 510(k)

KEANE UNI KNEE SYSTEM

K-Number: K910807 · 1991-06-27

ApplicantDepuy, Inc.
Decision Date1991-06-27
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KEANE UNI KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1991-06-27 under 510(k) number K910807. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KEANE UNI KNEE SYSTEM?

KEANE UNI KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-27. The listed applicant is Depuy, Inc.. The 510(k) number is K910807.

When did KEANE UNI KNEE SYSTEM receive FDA 510(k) clearance?

KEANE UNI KNEE SYSTEM received FDA 510(k) clearance on 1991-06-27, under 510(k) number K910807.

Who is the listed applicant for KEANE UNI KNEE SYSTEM?

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

What is the FDA product code for KEANE UNI KNEE SYSTEM?

The FDA product code for KEANE UNI KNEE SYSTEM is HSX.

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Other records listing Depuy, Inc. as applicant

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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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