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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone wedge
510(k) Number K151256
Device Name Arthrex BioSync® Bone Wedge
Arthex, Inc
1370 Creekside Boulevard
Naples,  FL  34108
Applicant Contact Laura Medlin
Arthex, Inc
1370 Creekside Boulevard
Naples,  FL  34108
Correspondent Contact Laura Medlin
Regulation Number888.3030
Classification Product Code
Subsequent Product Codes
Date Received05/12/2015
Decision Date 08/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls