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FDA 510(k)

GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM

K-Number: K953274 · 1996-02-05

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-02-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GENESIS POROUS TIBIAL TRAYS & REVISION 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 1996-02-05 under 510(k) number K953274. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM?

GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-05. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K953274.

When did GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM receive FDA 510(k) clearance?

GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM received FDA 510(k) clearance on 1996-02-05, under 510(k) number K953274.

Who is the listed applicant for GENESIS POROUS TIBIAL TRAYS & REVISION 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 POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM?

The FDA product code for GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM is JWH.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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