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FDA 510(k)

DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)

K-Number: K961379 · 1996-06-18

ApplicantDepuy, Inc.
Decision Date1996-06-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1996-06-18 under 510(k) number K961379. 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 AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) is a medical device that received FDA 510(k) clearance on 1996-06-18. The listed applicant is Depuy, Inc.. The 510(k) number is K961379.

When did DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) receive FDA 510(k) clearance?

DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) received FDA 510(k) clearance on 1996-06-18, under 510(k) number K961379.

Who is the listed applicant for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

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 AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

The FDA product code for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) is 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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