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
121–144 of 899
Cleared Jan 23, 2023
CD Horizon Spinal System
K223494
Medtronic
Orthopedic · 63d
Cleared Jan 11, 2023
NuVasive Reline System
K223181
Nu Vasive, Incorporated
Orthopedic · 92d
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
K223565
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Dec 22, 2022
ASTRA Spine System
K223273
Spinecraft, LLC
Orthopedic · 59d
Cleared Dec 05, 2022
Zavation Spinal System
K222614
Zavation Medical Products, LLC
Orthopedic · 97d
Cleared Dec 01, 2022
Mercury® II Spinal System
K222516
Spinal Elements, Inc.
Orthopedic · 104d
Cleared Nov 28, 2022
Momentum® MIS Posterior Spinal Fixation System
K223274
Ulrich Medical USA
Orthopedic · 35d
Cleared Nov 15, 2022
Dyflex-II
K212700
Taeyeon Medical Co., Ltd.
Orthopedic · 447d
Cleared Oct 28, 2022
Spinal Inner Fixation System
K222031
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Orthopedic · 109d
Cleared Oct 25, 2022
Rexious Spinal Fixation System
K222415
Dio Medical Corporation
Orthopedic · 76d
Cleared Oct 13, 2022
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
K222473
Medos International SARL
Orthopedic · 58d
Cleared Oct 04, 2022
CD HORIZON™ ASTUTE™ SPINAL SYSTEM
K221646
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 16, 2022
Altus Spine Pedicle Screw System
K211027
Altus Partners, LLC
Orthopedic · 528d
Cleared Sep 16, 2022
True Tulip, True M.I.S.
K220297
Innovative Surgical Designs, Inc.
Orthopedic · 226d
Cleared Sep 07, 2022
Mariner RDX System
K222110
SeaSpine Orthopedics Corporation
Orthopedic · 51d
Cleared Aug 31, 2022
Sterile Posterior Spinal Fixation System
K221745
Shanghai Reach Medical Instrument Co, Ltd.
Orthopedic · 76d
Cleared Aug 29, 2022
Salvo® Spine System
K222362
Spine Wave, Inc.
Orthopedic · 25d
Cleared Aug 19, 2022
Cortera Spinal Fixation System
K221403
Surgalign Spine Technologies
Orthopedic · 95d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776
Corelink, LLC
Orthopedic · 49d
Cleared Jul 28, 2022
OsteoCentric Spine MIS Pedicle Fastener System
K221332
OsteoCentric Technologies
Orthopedic · 80d
Cleared Jul 28, 2022
INERTIA CONNEXX Modular Pedicle Screw System
K221905
Nexxt Spine, LLC
Orthopedic · 28d
Cleared Jul 22, 2022
Kentrospine PSS Pedicle Screw System
K220486
Rivarp Medical Private Limited
Orthopedic · 150d
Cleared Jun 23, 2022
EDEN Spinal Fixation System
K201788
Jmt Co., Ltd.
Orthopedic · 723d
Cleared Jun 09, 2022
KHEIRON® Spinal Fixation System
K211981
S.M.A.I.O
Orthopedic · 349d