NKB · Class II · 21 CFR 888.3070

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
697–720 of 905
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d
Cleared Nov 15, 2010
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
K102204
Choicespine, LP
Orthopedic · 102d
Cleared Oct 20, 2010
VIPER SPINE SYSTEM
K102701
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Oct 18, 2010
MODIFICATION TO:EXPEDIUM SPINE SYSTEM
K101933
Depuy Spine, Inc.
Orthopedic · 98d
Cleared Oct 07, 2010
EXCELLA II SPINAL SYSTEM MODEL EC2-00
K102248
Innovasis, Inc.
Orthopedic · 59d
Cleared Sep 30, 2010
TSRH(R) SPINAL SYSTEM
K101772
Medtronic Sofamor Danek
Orthopedic · 98d
Cleared Sep 27, 2010
CD HORIZON SPINAL SYSTEM
K091445
Medtronic Sofamor Danek
Orthopedic · 500d
Cleared Sep 21, 2010
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
K100845
Zimmer Spine, Inc.
Orthopedic · 180d
Cleared Aug 31, 2010
EXPEDIUM SPINE SYSTEM
K101070
Medos International SARL
Orthopedic · 137d
Cleared Aug 24, 2010
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235
Stryker Spine
Orthopedic · 15d
Cleared Aug 12, 2010
STAINLESS STEEL SPINAL SYSTEM
K100970
Theken Spine, LLC
Orthopedic · 126d
Cleared Aug 11, 2010
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692
Pioneer Surgical Technology
Orthopedic · 254d
Cleared Aug 06, 2010
LANX SPINAL FIXATION SYSTEM
K100935
Lanx, Inc.
Orthopedic · 123d
Cleared Aug 05, 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952
Synthes Spine
Orthopedic · 121d
Cleared Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926
Blackstone Medical, Inc.
Orthopedic · 218d
Cleared Jul 23, 2010
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
K100147
Aesculap Implant System, Inc.
Orthopedic · 185d
Cleared Jul 08, 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144
Stryker Spine
Orthopedic · 76d
Cleared Jul 01, 2010
SYNTHES MATRIX SYSTEM
K100634
Synthes (Usa)
Orthopedic · 118d
Cleared Jul 01, 2010
TILOCK PEDICLE SCREW SYSTEM
K100757
Genesys Spine
Orthopedic · 106d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438
Ebi, L.P.
Orthopedic · 126d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
Cleared May 17, 2010
POLARIS SPINAL SYSTEM
K100220
Ebi, L.P.
Orthopedic · 111d
Cleared May 14, 2010
COCR RODS
K100788
Globus Medical, Inc.
Orthopedic · 53d
Cleared Apr 30, 2010
TSRH SPINAL SYSTEM
K091797
Medtronic Sofamor Danek
Orthopedic · 317d