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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K071456
Device Name ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Applicant Contact MARIELA CABARCAS
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Correspondent Contact MARIELA CABARCAS
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received05/25/2007
Decision Date 01/17/2008
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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