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510(k) K254249

HKT Anatomical Locking Trauma System by Hankil Tech Medical Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2026
Date Received
December 29, 2025
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 Hankil Tech Medical Co., Ltd.

  • K231213 — HKT Anatomical Locking Trauma System (January 19, 2024)

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