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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
Applicant
Arthex, Inc
1370 Creekside Boulevard
Naples,  FL  34108
Applicant Contact Laura Medlin
Correspondent
Arthex, Inc
1370 Creekside Boulevard
Naples,  FL  34108
Correspondent Contact Laura Medlin
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Codes
HRS   HWC  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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