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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 7 of 7 Results
ProductCode: KWS Applicant: HOWMEDICA OSTEONICS CORP Decision Date To: 08/10/2022
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osteonics solar shoulder humeral bearing head HOWMEDICA OSTEONICS CORP. K990598 03/15/1999
solar shoulder offset humeral head HOWMEDICA OSTEONICS CORP. K001419 07/27/2000
solar purefix ha shoulder HOWMEDICA OSTEONICS CORP K061677 07/10/2006
solar reunion fracture stem HOWMEDICA OSTEONICS CORP. K062113 10/03/2006
special orthopaedic solutions glenoid shoulder component HOWMEDICA OSTEONICS CORP K103104 11/22/2010
reunion tsa system-humeral press-fit & cemented stems model 5569-yy-20xx (yy=p,c; xx=07-17,06l-12l) reunion tsa system n HOWMEDICA OSTEONICS CORP K103835 05/05/2011
reunion rsa shoulder system HOWMEDICA OSTEONICS CORP K130895 12/27/2013