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510(k) K223118

OIC Variable Angle Small Fragment Locking Plate System by Orthopaedic Implant Company — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2023
Date Received
October 3, 2022
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

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  • 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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