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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K113828
Device Name DYNANAIL ANKLE ARTHRODESIS NAIL
Applicant
MedShape, Inc.
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Applicant Contact JEREMY BLAIR
Correspondent
MedShape, Inc.
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Correspondent Contact JEREMY BLAIR
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/27/2011
Decision Date 02/29/2012
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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