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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 K031219
Device Name MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
Applicant
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Applicant Contact MARY BIGGERS
Correspondent
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Correspondent Contact MARY BIGGERS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/17/2003
Decision Date 05/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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