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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 K132783
Device Name EXOSHAPE DUO SOFT TISSUE FASTENER
Applicant
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Applicant Contact STEPHEN LAFFOON
Correspondent
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Correspondent Contact STEPHEN LAFFOON
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received09/06/2013
Decision Date 12/09/2013
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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