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510(k) K240035

TACTIX Vector Syndesmosis System by Vilex, LLC — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
January 4, 2024
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

  • K253727 — Syndesmosis TightRope PRO (December 22, 2025)
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  • K243624 — Acu-Sinch Knotless Mini (January 23, 2025)
  • K242091 — Bolo Button System (December 23, 2024)
  • K243408 — TACTIX Vector Syndesmosis System (November 27, 2024)
  • K242311 — EXPERT - Flexible Joint Fixation System (November 1, 2024)
  • K240947 — TENSOR® Suture Button System (June 3, 2024)
  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)
  • K232780 — CC-Clip® Implant System (December 18, 2023)