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FDA 510(k)

KEANE UNI KNEE SYSTEM WITH POROCOAT

K-Number: K921232 · 1992-06-09

ApplicantDepuy, Inc.
Decision Date1992-06-09
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KEANE UNI KNEE SYSTEM WITH POROCOAT is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921232. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEANE UNI KNEE SYSTEM WITH POROCOAT?

KEANE UNI KNEE SYSTEM WITH POROCOAT is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Depuy, Inc.. The 510(k) number is K921232.

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

KEANE UNI KNEE SYSTEM WITH POROCOAT received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921232.

Who is the listed applicant for KEANE UNI KNEE SYSTEM WITH POROCOAT?

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 WITH POROCOAT?

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

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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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