FDA 510(k) Application Details - K111352

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K111352
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F TAMPA, FL 33610 US Other 510(k) Applications for this Company
Contact	SETH MASEK 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	05/13/2011
Decision Date	08/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review