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FDA 510(k)

AMK MODULAR TIBIAL WEDGE SYSTEM

K-Number: K904205 · 1990-10-22

ApplicantDepuy, Inc.
Decision Date1990-10-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMK MODULAR TIBIAL WEDGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K904205. 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 MODULAR TIBIAL WEDGE SYSTEM?

AMK MODULAR TIBIAL WEDGE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Depuy, Inc.. The 510(k) number is K904205.

When did AMK MODULAR TIBIAL WEDGE SYSTEM receive FDA 510(k) clearance?

AMK MODULAR TIBIAL WEDGE SYSTEM received FDA 510(k) clearance on 1990-10-22, under 510(k) number K904205.

Who is the listed applicant for AMK MODULAR TIBIAL WEDGE SYSTEM?

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 MODULAR TIBIAL WEDGE SYSTEM?

The FDA product code for AMK MODULAR TIBIAL WEDGE SYSTEM is JWH.

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Other records listing Depuy, 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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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