FDA 510(k) Application Details - K132740

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K132740
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	PAUL L SPEIDEL Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2013
Decision Date	11/26/2013
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