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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 117 Results
ProductCode: HRS Applicant: SYNTHES (USA) Decision Date To: 11/28/2022
 
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2.4mm va-lcp dorsal distal radius plates SYNTHES (USA) K102694 12/09/2010
2.4mm va-lcp intercarpal fusion system SYNTHES (USA) K103243 01/21/2011
2.7/3.5mm va-lcp anteriro clavicle plate system SYNTHES (USA) LLC K101536 09/15/2010
2.7mm lcp ulna osteotomy system SYNTHES (USA) PRODUCTS LLC K113364 02/29/2012
depuy synthes 2.4mm lcp straight wrist plate, sterile Synthes (USA) Products LLC K192327 11/07/2019
depuy synthes 3.5/4.5 mm variable angle lcp periprosthetic proximal femur plating system Synthes (USA) products, LLC K210205 03/26/2021
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 craniomaxillofacial sternal devices - mr conditional Synthes (USA) Products LLC K190963 07/23/2019
depuy synthes tomofix osteotomy system SYNTHES (USA) PRODUCTS LLC K141796 08/29/2014
depuy synthes trauma orthopedic plates and screws Synthes (USA) Products LLC/DePuy Orthopaedics Inc K180310 11/01/2018
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