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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 K091309
Device Name REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
Applicant
Dgimed Ortho, Inc.
12400 Whitewater Dr.,
Suite 2010
Minnetonka,  MN  55343
Applicant Contact SCOTT YOUNGSTROM
Correspondent
Dgimed Ortho, Inc.
12400 Whitewater Dr.,
Suite 2010
Minnetonka,  MN  55343
Correspondent Contact SCOTT YOUNGSTROM
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/04/2009
Decision Date 11/05/2009
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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