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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 K912420
Device Name ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
Applicant
Scientific Research
1220 19th St. NW
Suite 202
Washington,  DC  20036
Applicant Contact BRUCE K BERNARD
Correspondent
Scientific Research
1220 19th St. NW
Suite 202
Washington,  DC  20036
Correspondent Contact BRUCE K BERNARD
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/31/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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