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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 K961027
Device Name ORTHOFIX TIBIAL NAILING SYSTEM
Applicant
ORTHOFIX, INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE,  MD  20852
Applicant Contact ROBERT L SHERIDAN
Correspondent
ORTHOFIX, INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE,  MD  20852
Correspondent Contact ROBERT L SHERIDAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/14/1996
Decision Date 05/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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