Medical Device Manufacturer · US , 19380 , PA

Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. - FDA 510(k) C...

5 submissions · 5 cleared · Since 2017

Recent clearances: DePuy Synthes Trauma Screws, DePuy Synthes Sterilization Container System, DePuy Synthes Trauma Orthopedic Plates and Screws

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. Orthopedic ✕

4 devices

1-4 of 4

Cleared Nov 26, 2019

DePuy Synthes Trauma Screws

Orthopedic · 57d

Cleared Nov 01, 2018

DePuy Synthes Trauma Orthopedic Plates and Screws

Orthopedic · 269d

Cleared Jun 21, 2018

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional,...

Orthopedic · 267d

Cleared Jun 30, 2017

DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy...

Orthopedic · 487d