FDA 510(k) Application Details - K031219

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K031219
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	ORTHOFIX, INC. 1720 BRAY CENTRAL DR. MCKINNEY, TX 75069 US Other 510(k) Applications for this Company
Contact	MARY BIGGERS Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2003
Decision Date	05/28/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review