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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 17 Results
ProductCode: KWY Applicant: SMITH & NEPHEW, INC. Decision Date To: 01/22/2022
 
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polarstem calcar reamer guide Smith & Nephew, Inc. K211548 07/19/2021
redapt porous acetabular shell Smith & Nephew, Inc. K181366 09/24/2018
birmingham hip (bh) dual mobility insert Smith & Nephew, Inc. K171934 11/30/2017
polarstem collared (standard and lateral) and valgus femoral stem with ti/ha SMITH & NEPHEW, INC. K143739 04/20/2015
sl-plus mia and sl-plus femoral stems with ti/ha Smith & Nephew, Inc. K143096 03/24/2015
smith & nephew global femoral head trials SMITH & NEPHEW, INC. K132435 10/22/2013
polarstem standard and lateral femoral stems with ti/ha SMITH & NEPHEW, INC. K130728 10/10/2013
smith & nephew, inc. hip system instrumentation SMITH & NEPHEW, INC. K123598 06/28/2013
sl-plus mia femoral stems with ti/ha coating SMITH & NEPHEW, INC. K122296 08/28/2012
polarcup dual mobility system SMITH & NEPHEW, INC. K122244 08/23/2012
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