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510(k) K212990

Acumed Ankle Syndesmosis Repair System by Acumed, LLC — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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Other clearances for product code HTN

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  • K243408 — TACTIX Vector Syndesmosis System (November 27, 2024)
  • K242311 — EXPERT - Flexible Joint Fixation System (November 1, 2024)
  • K240035 — TACTIX Vector Syndesmosis System (August 1, 2024)
  • K240947 — TENSOR® Suture Button System (June 3, 2024)
  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)