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FDA 510(k)

GENESIS UNICOMPARTMENTAL KNEE SYSTEM

K-Number: K912735 · 1991-12-27

ApplicantSmith & Nephew Richards, Inc.
Decision Date1991-12-27
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GENESIS UNICOMPARTMENTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K912735. 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 GENESIS UNICOMPARTMENTAL KNEE SYSTEM?

GENESIS UNICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K912735.

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

GENESIS UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 1991-12-27, under 510(k) number K912735.

Who is the listed applicant for GENESIS UNICOMPARTMENTAL KNEE SYSTEM?

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

What is the FDA product code for GENESIS UNICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for GENESIS UNICOMPARTMENTAL KNEE SYSTEM is HSX.

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Other records listing Smith & Nephew Richards, 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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