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510(k) K252356

The Acumed Wrist Fixation System - 2.4mm Screws by Acumed, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2025
Date Received
July 29, 2025
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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  • K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (December 29, 2022)
  • K212990 — Acumed Ankle Syndesmosis Repair System (January 7, 2022)
  • K210750 — Acumed Clavicle Hook Plating System (July 15, 2021)
  • K151886 — Acumed Ankle and Small Fragment Base Set Update (October 30, 2015)
  • K143385 — Acumed Ankle Plating System (April 6, 2015)

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