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
745–768 of 905
Cleared Jul 15, 2009
CD HORIZON SPINAL SYSTEM
K091442
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jul 14, 2009
5.5 POLARIS SPINAL SYSTEM
K091067
Biomet Spine
Orthopedic · 91d
Cleared Jul 02, 2009
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
K083004
Aesculap Implant Systems, Inc.
Orthopedic · 267d
Cleared Jul 02, 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981
Nuvasive, Inc.
Orthopedic · 86d
Cleared Jul 01, 2009
POLARIS SPINAL SYSTEM
K090523
Ebi, L.P.
Orthopedic · 125d
Cleared Jul 01, 2009
MERCURY SPINAL SYSTEM
K091587
Spinal Elements, Inc.
Orthopedic · 29d
Cleared Jun 24, 2009
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
K091291
Stryker Spine
Orthopedic · 54d
Cleared Jun 10, 2009
VIPER 2 SYSTEM
K090648
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Jun 10, 2009
THEKEN CORAL SPINAL SYSTEM
K091266
Theken Spine, LLC
Orthopedic · 41d
Cleared May 15, 2009
CD HORIZON SPINAL SYSTEM
K090390
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Apr 22, 2009
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K090799
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Apr 01, 2009
XIA 3 SPINAL SYSTEM
K083393
Stryker Spine
Orthopedic · 135d
Cleared Mar 06, 2009
EXPEDIUM SPINE SYSTEM
K090230
Depuy Spine, Inc.
Orthopedic · 35d
Cleared Jan 22, 2009
MERCURY SPINAL SYSTEM
K082353
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Jan 13, 2009
NEWPORT SPINAL SYSTEM
K083089
Seaspine, Inc.
Orthopedic · 89d
Cleared Jan 09, 2009
REVOLVE STABILIZATION SYSTEM
K083416
Globus Medical, Inc.
Orthopedic · 52d
Cleared Dec 11, 2008
CLAMPFIX
K082914
Synthes Spine
Orthopedic · 72d
Cleared Dec 03, 2008
MERCURY SPINAL SYSTEM
K083230
Spinal Elements, Inc.
Orthopedic · 30d
Cleared Nov 24, 2008
USS ILIOSACRAL, USS POLYAXIAL
K082572
Synthes Spine
Orthopedic · 80d
Cleared Nov 21, 2008
TSRH SPINAL SYSTEM
K081080
Medtronic Sofamor Danek
Orthopedic · 219d
Cleared Nov 13, 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028
Nuvasive, Inc.
Orthopedic · 34d
Cleared Oct 31, 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797
Blackstone Medical, Inc.
Orthopedic · 24d
Cleared Oct 10, 2008
CD HORIZON SPINAL SYSTEM
K082236
Medtronic Sofamor Danek
Orthopedic · 64d