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
601–624 of 905
Cleared Sep 11, 2012
NUVASIVE PRECEPT SPINAL SYSTEM
K122352
Nuvasive, Inc.
Orthopedic · 39d
Cleared Sep 10, 2012
LANX SPINAL FIZATION SYSTEM
K121316
Lanx, Inc.
Orthopedic · 131d
Cleared Aug 28, 2012
XIA 3 SPINAL SYSTEM
K113666
Stryker Spine
Orthopedic · 259d
Cleared Aug 24, 2012
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
K121103
Ldr Spine USA, Inc.
Orthopedic · 135d
Cleared Aug 24, 2012
NUVASIVE POLYAXIAL SPINAL SCREWS
K121619
Nuvasive, Inc.
Orthopedic · 84d
Cleared Aug 21, 2012
CD HORIZON SPINAL SYSTEM
K121764
Medtronic Sofamor Danek, Inc.
Orthopedic · 67d
Cleared Aug 17, 2012
LANX SPINAL FIXATION SYSTEM
K122145
Lanx, Inc.
Orthopedic · 29d
Cleared Aug 13, 2012
ERISMA-LP
K120469
Clariance
Orthopedic · 179d
Cleared Aug 09, 2012
PICASSO MIS SPINAL FIXATION SYSTEM
K120714
Accel Spine
Orthopedic · 154d
Cleared Aug 07, 2012
NAUTILUS SPINAL SYSTEM
K111953
Life Spine
Orthopedic · 393d
Cleared Aug 02, 2012
LANX SPINAL FIXATION SYSTEM
K121940
Lanx, Inc.
Orthopedic · 31d
Cleared Jul 31, 2012
SYNTHES MATRIX SYSTEM
K120838
Synthes Spine
Orthopedic · 133d
Cleared Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
K120467
Spinal Elements, Inc.
Orthopedic · 166d
Cleared Jul 30, 2012
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
K121299
Safe Orthopaedics
Orthopedic · 91d
Cleared Jul 26, 2012
BEACON STABILIZATION SYSTEM
K121922
Globus Medical, Inc.
Orthopedic · 24d
Cleared Jul 18, 2012
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K121671
Zimmer Spine, Inc.
Orthopedic · 42d
Cleared Jul 16, 2012
CALYPSO SYSTEM
K120564
Hogan Lovells US LLP
Orthopedic · 143d
Cleared Jul 05, 2012
CD HORIZON SPINAL SYSTEM
K121680
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jun 22, 2012
XIA 4.5 SPINAL SYSTEM
K121342
Stryker Corp.
Orthopedic · 49d
Cleared Jun 15, 2012
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
K121130
Biomet Spine
Orthopedic · 63d
Cleared Jun 14, 2012
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136
Depuy Spine, Inc.
Orthopedic · 419d
Cleared Jun 14, 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395
Globus Medical, Inc.
Orthopedic · 210d
Cleared Jun 07, 2012
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
K112607
Spinevision S.A.
Orthopedic · 274d
Cleared May 30, 2012
STAINLESS STEEL SPINAL SYSTEM
K120829
Theken Spine, LLC
Orthopedic · 72d