FDA Product Code NKB: Thoracolumbosacral Pedicle Screw System
FDA product code NKB covers thoracolumbosacral pedicle screw systems.
These spinal implants are designed to provide immobilization and stabilization of the thoracic, lumbar, and sacral spine. Pedicle screws are inserted into the vertebral pedicles and connected via rods to correct deformity, treat fractures, or facilitate fusion.
NKB devices are Class II medical devices, regulated under 21 CFR 888.3070 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medtronic Sofamor Danek USA, Inc., Medtronic Sofamor Danek and Depuy Spine, Inc..
905
Total
905
Cleared
101d
Avg days
2003
Since
905 devices
Cleared
Jul 23, 2004
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
Pioneer Surgical Technology
Orthopedic
80d
Cleared
Mar 31, 2004
MERLIN SPINE SYSTEM
Depuy Spine, Inc.
Orthopedic
105d
Cleared
Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
202d
Cleared
Jan 13, 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
Ebi, L.P.
Orthopedic
91d
Cleared
Sep 12, 2003
CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
73d
Cleared
Aug 08, 2003
OPUS SPINAL SYSTEM
Howmedica Osteonics Corp.
Orthopedic
185d
Cleared
Jul 22, 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
Ebi, L.P.
Orthopedic
84d
Cleared
Jul 22, 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
Ebi, L.P.
Orthopedic
77d
Cleared
Jul 17, 2003
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
Spinal Concepts, Inc.
Orthopedic
189d
Cleared
Mar 28, 2003
SPINAL CONCEPTS INC. PATHFINDER
Spinal Concepts, Inc.
Orthopedic
29d
Cleared
Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
28d