FDA 510(k) Application Details - K140613

Device Classification Name	More FDA Info for this Device
510(K) Number	K140613
Device Name	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Applicant	ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 IRVINE, CA 92618-0000 US Other 510(k) Applications for this Company
Contact	John McIntyre Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2014
Decision Date	09/18/2014
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