FDA 510(k) Application Details - K150885

Device Classification Name	More FDA Info for this Device
510(K) Number	K150885
Device Name	MAGEC 2 Spinal Bracing and Distraction System
Applicant	Ellipse Technologies, Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	REBECCA SHELBURNE 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	04/02/2015
Decision Date	05/29/2015
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