FDA Product Code NQW: Orthosis, Spine, Plate, Laminoplasty, Metal
Under FDA product code NQW, laminoplasty spinal plates are cleared for posterior cervical spine reconstruction after laminoplasty procedures.
These metal plates are attached to the laminae and lateral masses to hold the opened laminae in an elevated position after laminoplasty, maintaining the expanded spinal canal and protecting the spinal cord while enabling bone healing across the opened hinge.
NQW devices are Class II medical devices, regulated under 21 CFR 888.3050 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Globus Medical, Inc., Seaspine, Inc. and Life Spine, Inc..
30
Total
30
Cleared
98d
Avg days
2004
Since
30 devices
Cleared
May 12, 2009
LAMINOPLASTY PLATING SYSTEM
Aesculap Implant System, Inc.
Orthopedic
90d
Cleared
Jul 25, 2008
RELIEVE LAMINOPLASTY FIXATION SYSTEM
Globus Medical, Inc.
Orthopedic
137d
Cleared
Jun 06, 2005
CENTERPIECE PLATE FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
144d
Cleared
Feb 18, 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
Blackstone Medical, Inc.
Orthopedic
77d
Cleared
Apr 01, 2004
SYNTHES AFS
Synthes Spine
Orthopedic
230d