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510(k) K252196

Arthrex FibuLock Nail System by Arthrex, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2026
Date Received
July 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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  • K251994 — Arthrex Synergy Vision Imaging System (October 16, 2025)
  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 2025)

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