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FDA 510(k)

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS

K-Number: K032151 · 2003-09-26

ApplicantDepuy, Inc.
Decision Date2003-09-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K032151. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS?

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Depuy, Inc.. The 510(k) number is K032151.

When did DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS receive FDA 510(k) clearance?

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS received FDA 510(k) clearance on 2003-09-26, under 510(k) number K032151.

Who is the listed applicant for DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS?

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 DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS?

The FDA product code for DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS is JWH.

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Related Devices (Code: JWH)

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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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