FDA 510(k) Application Details - K153031

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K153031
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	K2M, Incorporated 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	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2015
Decision Date	11/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review