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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 28 Results
ProductCode: HSB Applicant: SYNTHES (USA) Decision Date To: 12/01/2022
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depuy synthes retrograde femoral nail advanced system, depuy synthes locking screws for medullary nails, 5.0 mm Synthes (USA) Products, LLC K201346 09/23/2020
depuy synthes femoral recon nail system Synthes (USA) Products, LLC K172157 11/14/2017
depuy synthes 4.0 mm and 5.0 mm locking screws – mr conditional, depuy synthes wrist fusion plate (wfp) – mr conditional, depuy synthes large fragment dynamic compression locking (dcl) system –mr conditional, depuy synthes small fragment dynamic compression locking (dcl) system – mr conditional, de SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC K160553 06/30/2017
depuy synthes tfna augmentation system Synthes (USA) Products, LLC K160167 09/26/2016
synthes synsonic ulna nail SYNTHES (USA) K131984 03/31/2014
synthes trochanteric fixation nail - advanced system SYNTHES (USA) PRODUCTS, LLC K131548 02/28/2014
synthes brainlab trauma compatible instruments SYNTHES (USA) PRODUCTS LLC K111891 11/28/2011
synthes multiloc proximal humeral nailing system SYNTHES (USA) K103002 03/02/2011
synthes (usa) trochanteric fixation nail (tfn) screw SYNTHES (USA) K092646 09/25/2009
synthes angular stable locking system (asls) SYNTHES (USA) K090241 06/17/2009