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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K241592
Device Name Arthrex VAL and VAL KreuLock™ Compression Screw System
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact Konrad Wolfmeyer
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact Konrad Wolfmeyer
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received06/03/2024
Decision Date 08/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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