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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, Nondegradable, Soft Tissue
510(k) Number K102539
Device Name ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
Applicant
Shoulder Options, Inc.
100 E. S. Main St., P.O. Box 1458
Waxhaw,  NC  28173
Applicant Contact JOHN KAPITAN
Correspondent
Shoulder Options, Inc.
100 E. S. Main St., P.O. Box 1458
Waxhaw,  NC  28173
Correspondent Contact JOHN KAPITAN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/03/2010
Decision Date 02/24/2011
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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