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FDA 510(k)

AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY

K-Number: K925837 · 1994-01-07

ApplicantDepuy, Inc.
Decision Date1994-01-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K925837. 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 AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY?

AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Depuy, Inc.. The 510(k) number is K925837.

When did AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY receive FDA 510(k) clearance?

AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY received FDA 510(k) clearance on 1994-01-07, under 510(k) number K925837.

Who is the listed applicant for AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY?

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 AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY?

The FDA product code for AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY 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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