FDA 510(k) Application Details - K141739

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K141739
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 IRVINE, CA 92618-0000 US Other 510(k) Applications for this Company
Contact	REBECCA SHELBURNE 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	06/27/2014
Decision Date	10/07/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review