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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 9 of 9 Results
ProductCode: KWS Applicant: SMITH & NEPHEW, INC. Decision Date To: 03/24/2023
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aetos shoulder system Smith & Nephew, Inc. K220847 01/03/2023
titan total shoulder system (tss), titan reverse shoulder system (rss), titan humeral resurfacing arthroplasty system (hra), modular radial head system (mrh), katalyst bipolar radial head system (katalyst) Smith & Nephew, Inc. K213827 03/11/2022
smith & nephew, inc. shoulder system instruments SMITH & NEPHEW, INC. K121714 09/07/2012
promos modular shoulder system SMITH & NEPHEW, INC. K113012 01/05/2012
modular neer 3 humeral stems and modular neer 3 humeral heads SMITH & NEPHEW, INC. K030344 03/04/2003
vaporized hydrogen peroxide (vhp) sterilization of unmwpe components in the cofield total shoulder system, the neer ii SMITH & NEPHEW, INC. K012788 03/15/2002
3d humeral heads SMITH & NEPHEW, INC. K012378 12/13/2001
cofield eccentric and lateral offset humeral heads SMITH & NEPHEW, INC. K003566 02/14/2001
neer iii total shoulder system SMITH & NEPHEW, INC. K994350 05/23/2000
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