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510(k) K252081

SportLinc Syndesmosis Device by Lincotek Medical — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2026
Date Received
July 2, 2025
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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