FDA 510(k) Application Details - K121276

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K121276
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	NEUROVENTION LLC 4628 NORTHPARK DRIVE MEREDITH MAY, CO 80918 US Other 510(k) Applications for this Company
Contact	MEREDITH MAY 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	04/27/2012
Decision Date	08/29/2012
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