FDA 510(k) K132403, ANNEXTM ADJACENT LEVEL SYSTEM, by Spine Wave, Inc.

510(K) Number: K132403
Device Name: ANNEXTM ADJACENT LEVEL SYSTEM
Manufacturer: Spine Wave, Inc.
Device Classification Name: orthosis, spondylolisthesis spinal fixation
Regulation Number: 888.3070
Classification Product Code: MNH
Date Received: 08/01/2013
Decision Date: 01/10/2014
Regulation Medical Specialty: Orthopedic