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510(k) K192745

DePuy Synthes Trauma Screws by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

  • K181933 — DePuy Synthes Sterilization Container System (May 9, 2019)
  • K180310 — DePuy Synthes Trauma Orthopedic Plates and Screws (November 1, 2018)
  • K172975 — DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy (June 21, 2018)
  • K160553 — DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes W (June 30, 2017)

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