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510(k) K243408

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
November 1, 2024
Clearance Type
Special
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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  • K242091 — Bolo Button System (December 23, 2024)
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  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)
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