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510(k) K243798

Orthex External Fixation System by OrthoPediatrics Corp. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2025
Date Received
December 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K223786 — Orthex External Fixation System (February 10, 2023)
  • K220679 — Pediatric Nailing Platform Femur (July 20, 2022)

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  • K241563 — Extremity Medical External Fixation System (February 21, 2025)