FDA 510(k) Application Details - K121630

Device Classification Name	More FDA Info for this Device
510(K) Number	K121630
Device Name	RANGE SPINAL SYSTEM
Applicant	K2M, INC. 751 MILLER DR., S.E., SUITE F1 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	OSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2012
Decision Date	09/11/2012
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review