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510(k) K181933

DePuy Synthes Sterilization Container System by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2019
Date Received
July 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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

  • K192745 — DePuy Synthes Trauma Screws (November 26, 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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