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FDA 510(k)

Vario-Cup System

K-Number: K221794 · 2022-07-20

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2022-07-20
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vario-Cup System is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-07-20 under approval number K221794. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vario-Cup System?

Vario-Cup System is a medical device that received FDA 510(k) clearance on 2022-07-20. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K221794.

When was Vario-Cup System approved by the FDA?

Vario-Cup System received FDA 510(k) clearance on 2022-07-20, under approval number K221794.

What company makes Vario-Cup System?

Vario-Cup System is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for Vario-Cup System?

The FDA product code for Vario-Cup System is KWY.

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

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Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K173455SurgTech Bipolar Head SystemSurgtech, Inc. K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K192236Fitmore Hip StemZimmer GmbH

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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