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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: KRO Applicant: SMITH & NEPHEW, INC. Decision Date To: 06/07/2024
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smith & nephew, inc. anthem total knee system, genesis uni knee system, journey bcs and ii knee systems, journey ii cr knee system, journey ii uni knee system, journey ii uk knee system, journey ii xr bi-cruciate retaining knee system, journey pfj system, journey uni knee system, legion hinge total Smith & Nephew, Inc. K230653 05/04/2023
genesis ii xlpe resurfacing patellar components Smith & Nephew, Inc. K150241 10/27/2015
smith & nephew, inc. total knee system instrumentation SMITH & NEPHEW, INC. K121393 08/07/2012
legion hinge knee system SMITH & NEPHEW, INC. K081111 07/23/2008
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