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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 K100312
Device Name DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
Applicant
DGIMED ORTHO, INC
12400 WHITEWATER DRIVE,
SUITE 2010
MINNETONKA,  MN  55343
Applicant Contact SCOTT P YOUNGSTROM
Correspondent
DGIMED ORTHO, INC
12400 WHITEWATER DRIVE,
SUITE 2010
MINNETONKA,  MN  55343
Correspondent Contact SCOTT P YOUNGSTROM
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/04/2010
Decision Date 04/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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