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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 39 Results
ProductCode: KTT Applicant: SYNTHES (USA) Decision Date To: 06/04/2023
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maxframe multi-axial correction system (aka maxframe) Synthes (USA) Products, LLC K211313 05/25/2021
depuy synthes trauma screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc K192745 11/26/2019
depuy synthes trauma orthopedic plates and screws Synthes (USA) Products LLC/DePuy Orthopaedics Inc K180310 11/01/2018
depuy synthes femoral neck system Synthes (USA) Products, LLC K182154 10/16/2018
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 brainlab trauma compatible instruments SYNTHES (USA) PRODUCTS LLC K111891 11/28/2011
synthes distraction osteogenesis system, mr conditional with expanded indications SYNTHES (USA) K092190 05/11/2010
synthes external fixation devices, mr conditional SYNTHES (USA) K090658 03/03/2010
synthes large external fixation, mr conditional SYNTHES (USA) K082650 11/18/2008