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510(k) K233311

Acumed Wrist Plating System by Acumed, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2024
Date Received
September 29, 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

Other clearances by Acumed, LLC

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  • K251296 — The Acumed Wrist Fixation System (June 18, 2025)
  • K243624 — Acu-Sinch Knotless Mini (January 23, 2025)
  • K230744 — Acumed Acutrak 3 Headless Compression Screw System (June 9, 2023)
  • 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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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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