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., CarboFix Orthopedics , Ltd. and SeaSpine Orthopedics Corporation.

899
Total
899
Cleared
100d
Avg days
2003
Since
899 devices
217–240 of 899
Cleared May 22, 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
K193423
Icotec AG
Orthopedic · 165d
Cleared May 19, 2020
Reform Pedicle Screw System
K200303
Precision Spine
Orthopedic · 103d
Cleared May 12, 2020
Dymaxeon Spine System
K192930
Back 2 Basics Direct, LLC
Orthopedic · 208d
Cleared Apr 30, 2020
CarboClear® II Pedicle Screw System
K200519
CarboFix Orthopedics , Ltd.
Orthopedic · 59d
Cleared Apr 24, 2020
EXPEDIUM® Spine System
K200245
Medos International S?rl
Orthopedic · 84d
Cleared Apr 23, 2020
ARx Spinal System
K200070
Life Spine, Inc.
Orthopedic · 101d
Cleared Apr 23, 2020
Stryker Xia 3 Power Adaptor
K200666
Stryker Spine
Orthopedic · 41d
Cleared Mar 24, 2020
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
K193100
OrthoPediatrics Corp.
Orthopedic · 137d
Cleared Mar 20, 2020
Nano FortiFix® System
K193211
Nanovis Spine, LLC
Orthopedic · 120d
Cleared Mar 06, 2020
MEGAFIX® Pedicle Screw Spinal System
K191655
Seohancare Co., Ltd.
Orthopedic · 259d
Cleared Mar 06, 2020
LOSPA® IS™ Spinal Fixation System
K200267
Corentec Co., Ltd.
Orthopedic · 32d
Cleared Feb 28, 2020
Daytona® Small Stature Spinal System
K200381
SeaSpine Orthopedics Corporation
Orthopedic · 10d
Cleared Feb 13, 2020
OrthoCircle Spine Pedicle Screw System
K193472
Orthocircle Spine
Orthopedic · 59d
Cleared Feb 05, 2020
PERLA® TL posterior osteosynthesis system
K193396
Spineart
Orthopedic · 61d
Cleared Jan 31, 2020
CapLOX II®/TowerLOX® MIS Pedicle Screw System
K193270
Captiva Spine, Inc.
Orthopedic · 66d
Cleared Jan 27, 2020
M.U.S.T. Pedicle Screw System
K193365
Medacta International S.A.
Orthopedic · 54d
Cleared Jan 15, 2020
NEX-D2 Posterior Fixation System
K190981
Next Orthosurgical
Orthopedic · 275d
Cleared Jan 14, 2020
Streamline TL Spinal Fixation System
K192800
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic · 106d
Cleared Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
K193011
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Jan 10, 2020
CorticaLINK Spinal Fusion Platform
K193465
Spine Smith Holdings, LLC
Orthopedic · 25d
Cleared Dec 18, 2019
Percusys® Plus Pedicle Screw System
K192680
Joimax GmbH
Orthopedic · 83d
Cleared Dec 17, 2019
G Surgical Marksman System
K193219
G Surgical, LLC
Orthopedic · 26d
Cleared Dec 12, 2019
Invictus™ Spinal Fixation System
K192938
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared Nov 26, 2019
Streamline MIS Spinal Fixation System
K192396
Pioneer Surgical Technology, Inc.
Orthopedic · 84d