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FDA 510(k)

PRESERVATION UNICOMPARTMENTAL KNEE

K-Number: K941606 · 1994-10-14

ApplicantDepuy, Inc.
Decision Date1994-10-14
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRESERVATION UNICOMPARTMENTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K941606. 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 PRESERVATION UNICOMPARTMENTAL KNEE?

PRESERVATION UNICOMPARTMENTAL KNEE is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Depuy, Inc.. The 510(k) number is K941606.

When did PRESERVATION UNICOMPARTMENTAL KNEE receive FDA 510(k) clearance?

PRESERVATION UNICOMPARTMENTAL KNEE received FDA 510(k) clearance on 1994-10-14, under 510(k) number K941606.

Who is the listed applicant for PRESERVATION UNICOMPARTMENTAL KNEE?

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 PRESERVATION UNICOMPARTMENTAL KNEE?

The FDA product code for PRESERVATION UNICOMPARTMENTAL KNEE 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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