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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 71 Results
ProductCode: HWC Applicant: SYNTHES (USA) Decision Date To: 05/04/2024
 
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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 tibial nail advanced, depuy synthes locking screws medullary nails, 4.0 and 5.0mm Synthes (USA) Products, LLC K201336 09/03/2020
depuy synthes trauma screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc K192745 11/26/2019
depuy synthes craniomaxillofacial sternal devices - mr conditional Synthes (USA) Products LLC K190963 07/23/2019
trumatch graft cage - long bone Synthes (USA) LLC K180821 12/21/2018
depuy synthes trauma orthopedic plates and screws Synthes (USA) Products LLC/DePuy Orthopaedics Inc K180310 11/01/2018
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 variable angle locking hand system (1.3 mm and 2.0 mm plates and screws) SYNTHES (USA) PRODUCTS, LLC K150099 03/23/2015
synthes 2.7mm and 3.5mm variable angle lcp midfoot/hindfoot system SYNTHES (USA) PRODUCTS LLC K131186 10/08/2013
synthes 3.5 mm va-lcp proximal tibia plate system SYNTHES (USA) PRODUCTS LLC K120689 06/04/2012
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