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510(k) K212601

DRPx Locking Distal Radius Plate System by Orthopaedic Implant Company — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2022
Date Received
August 17, 2021
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 Orthopaedic Implant Company

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  • K223118 — OIC Variable Angle Small Fragment Locking Plate System (January 21, 2023)
  • K202971 — DRPx Locking Distal Radius Plate System (May 6, 2021)
  • K211112 — OIC External Fixation System (May 5, 2021)
  • K183682 — OIC External Fixation System (April 8, 2019)
  • K182736 — OIC Suture Anchor System (December 28, 2018)
  • K181184 — OIC Intramedullary Nail System (July 27, 2018)
  • K171211 — OIC External Fixation System (September 27, 2017)

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