FDA 510(k) Application Details - K120899

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K120899
Device Name	Orthosis, Spinal Pedicle Fixation
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	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2012
Decision Date	05/25/2012
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