FDA 510(k) Application Details - K161028

Device Classification Name	More FDA Info for this Device
510(K) Number	K161028
Device Name	K2M Growing Spine System
Applicant	K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 US Other 510(k) Applications for this Company
Contact	Nancy Giezen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2016
Decision Date	07/22/2016
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