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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: HTY Applicant: SYNTHES (USA) Decision Date To: 05/10/2024
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depuy synthes trauma screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc K192745 11/26/2019
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
modification to synthes (usa) polypin SYNTHES (USA) K003527 04/09/2001
synthes (usa) locking condylar plate (lcp) system SYNTHES (USA) K000066 03/15/2000
synthes (usa) distal femur plate (dfp) system SYNTHES (USA) K982222 07/29/1998
synthes proximal femoral nail(pfn) system modification SYNTHES (USA) K973240 11/20/1997
synthes elastic intramedullary nail (ein) system SYNTHES (USA) K971783 07/18/1997
synthes (u.s.a.) polypin SYNTHES (USA) K961608 05/09/1997
synthes titanium diastal femoral nail (ti dfn) system SYNTHES (USA) K970733 04/02/1997
cannulated femoral nail SYNTHES (USA) K954856 03/08/1996
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