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510(k) K230971

APTUS® 3.5 TriLock Straight Plates by Medartis AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2023
Date Received
April 5, 2023
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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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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