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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 K111471
Device Name EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
Applicant
Medshape Solutions, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Applicant Contact JACK C GRIFFIS, III
Correspondent
Medshape Solutions, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Correspondent Contact JACK C GRIFFIS, III
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received05/27/2011
Decision Date 06/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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