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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K251690
Device Name Arthrex SpeedFLEX™ Implant
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact Emmarie Halteman
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact Emmarie Halteman
Regulation Number878.3300
Classification Product Code
OWY  
Subsequent Product Code
GAT  
Date Received06/02/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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