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510(k) K202912

ARIX Ankle Distal Tibia System by Jeil Medical Corporation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2020
Date Received
September 29, 2020
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

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • 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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