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510(k) K180310

DePuy Synthes Trauma Orthopedic Plates and Screws by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2018
Date Received
February 5, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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

  • K192745 — DePuy Synthes Trauma Screws (November 26, 2019)
  • K181933 — DePuy Synthes Sterilization Container System (May 9, 2019)
  • 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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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
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