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
361–384 of 905
Cleared Aug 01, 2017
M.U.S.T. Combined Set Screws
K171758
Medacta International S.A.
Orthopedic · 48d
Cleared Jul 24, 2017
True Spinal Fixation System
K171559
Innovative Surgical Designs, Inc.
Orthopedic · 55d
Cleared Jul 19, 2017
TiLock2 Spinal System
K171838
Genesys Spine
Orthopedic · 29d
Cleared Jul 14, 2017
True Spinal Fixation System
K170710
Innovative Surgical Designs, Inc.
Orthopedic · 128d
Cleared Jul 14, 2017
Vitality® Spinal Fixation System
K171907
Zimmer Biomet Spine, Inc.
Orthopedic · 18d
Cleared Jul 13, 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Jun 29, 2017
PHA S1 Spinal System
K163011
Phamedica, Inc.
Orthopedic · 244d
Cleared Jun 26, 2017
Swedge™ Pedicle Screw Fixation System
K170045
Spinal Resources, Inc.
Orthopedic · 172d
Cleared Jun 12, 2017
Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
K171509
Medyssey USA, Inc.
Orthopedic · 20d
Cleared Jun 08, 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821
Choicespine, LP
Orthopedic · 80d
Cleared Jun 02, 2017
Palisade™ Pedicular Fixation System
K171438
Spineology, Inc.
Orthopedic · 17d
Cleared May 25, 2017
SETx Pedicle Screw System
K170611
Xenco Medical, LLC
Orthopedic · 85d
Cleared May 25, 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170
Medacta International S.A.
Orthopedic · 34d
Cleared May 22, 2017
Dymaxeon Spine System
K170989
Back 2 Basics Direct, LLC
Orthopedic · 49d
Cleared May 16, 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496
Stryker Corporation
Orthopedic · 88d
Cleared May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
K170679
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared May 05, 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
K171082
Orthofix, Inc.
Orthopedic · 24d
Cleared May 04, 2017
VIPER PRIME™ Screws with Fenestrations
K170543
Medos International SARL
Orthopedic · 69d
Cleared May 02, 2017
Xultan 5.5 Pedicle Screw System
K170108
Met One Technologies
Orthopedic · 110d
Cleared Apr 26, 2017
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K170942
Choicespine, LP
Orthopedic · 27d
Cleared Apr 26, 2017
Zenius Spinal System
K170964
Medyssey USA, Inc.
Orthopedic · 26d
Cleared Apr 14, 2017
Threshold™ Pedicular Fixation System
K170251
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Threshold™ V2 Pedicular Fixation System
K170255
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Palisade™ Pedicular Fixation System
K170266
Spineology, Inc.
Orthopedic · 77d