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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 50 Results
ProductCode: JWH Applicant: SMITH & NEPHEW, INC. Decision Date To: 10/16/2021
 
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profix plus tibial insert, profix ps plus tibial insert, profix p/s tibial insert SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. K963255 01/02/1997
anthem cr total knee system Smith & Nephew, Inc. K170648 05/11/2017
anthem ps total knee system Smith & Nephew, Inc. K142807 12/22/2014
cemented round patella with jrny pegs Smith & Nephew, Inc. K221939 07/26/2022
cemented tibia baseplate no taper with jrny lock Smith & Nephew, Inc. K230555 03/30/2023
crosslinked polyethylene articular inserts SMITH & NEPHEW, INC. K071071 09/19/2007
genesis ii posterior stabilized high flexion articular insert SMITH & NEPHEW, INC. K032295 08/21/2003
genesis ii ps non-modular femoral component SMITH & NEPHEW, INC. K120698 05/18/2012
genesis ii total knee system, legion revision knee system, journey bcs knee system SMITH & NEPHEW, INC. K071790 08/17/2007
genesis ii xlpe resurfacing patellar components Smith & Nephew, Inc. K150241 10/27/2015
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