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510(k) K242995

OIC Small / Mini Fragment Plate System by The Orthopaedic Implant Company — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
September 26, 2024
Clearance Type
Special
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 The Orthopaedic Implant Company

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  • K223761 — OIC Intramedullary Screw System (February 13, 2023)
  • K223118 — OIC Variable Angle Small Fragment Locking Plate System (January 21, 2023)
  • K212601 — DRPx Locking Distal Radius Plate System (April 5, 2022)
  • 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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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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