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FDA 510(k)

Vanguard Complete Knee System

K-Number: K183583 · 2019-05-10

ApplicantZimmer, Inc.
Decision Date2019-05-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vanguard Complete Knee System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2019-05-10 under approval number K183583. 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 Vanguard Complete Knee System?

Vanguard Complete Knee System is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Zimmer, Inc.. The 510(k) number is K183583.

When was Vanguard Complete Knee System approved by the FDA?

Vanguard Complete Knee System received FDA 510(k) clearance on 2019-05-10, under approval number K183583.

What company makes Vanguard Complete Knee System?

Vanguard Complete Knee System is manufactured by Zimmer, Inc..

What is the FDA product code for Vanguard Complete Knee System?

The FDA product code for Vanguard Complete Knee System is JWH.

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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