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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 14 Results
ProductCode: HSX Applicant: SMITH & NEPHEW, INC. Decision Date To: 05/10/2024
 
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competitor unicondylar all-poly tibial baseplate SMITH & NEPHEW, INC. K061779 08/04/2006
competitor unicondylar knee tibial baseplate SMITH & NEPHEW, INC. K061011 07/11/2006
genesis unicondylar uhmwpe articular inserts SMITH & NEPHEW, INC. K100197 02/19/2010
journey ii uni tibial base and insert Smith & Nephew, Inc. K152315 10/28/2015
journey ii unicompartmental knee system Smith & Nephew, Inc. K191211 07/25/2019
journey unicondylar femoral implant SMITH & NEPHEW, INC. K073175 12/20/2007
journey unicondylar tibial baseplates SMITH & NEPHEW, INC. K102069 10/05/2010
modification to journey unicondylar femoral implant SMITH & NEPHEW, INC. K081351 07/24/2008
smith & nephew inc. unicompartmental and biocompartmental knee system instruments SMITH & NEPHEW, INC. K113038 01/05/2012
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
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