KWQ · Class II · 21 CFR 888.3060

FDA Product Code KWQ: Appliance, Fixation, Spinal Intervertebral Body

FDA product code KWQ covers spinal intervertebral body fixation appliances.

These devices are implanted between adjacent vertebral bodies to restore disc height, maintain spinal alignment, and facilitate interbody fusion. They include standalone interbody cages and spacers used in anterior, posterior, lateral, and oblique lumbar fusion approaches.

KWQ devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Nuvasive, Inc., Globus Medical, Inc. and K2m, Inc..

667
Total
667
Cleared
111d
Avg days
1979
Since
667 devices
193–216 of 667
Cleared Feb 10, 2016
Anterior Cervical Plate System
K151553
Osteomed Implantes, Ltda
Orthopedic · 246d
Cleared Dec 02, 2015
Zero-P Natural Plate System
K152239
Synthes (Usa), LLC
Orthopedic · 114d
Cleared Nov 20, 2015
Cam Lock Plating System
K152282
Life Spine, Inc.
Orthopedic · 100d
Cleared Nov 12, 2015
ATLANTIS Anterior Cervical Plate System
K152623
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Oct 15, 2015
Amendia Cervical Plate System
K152455
Amendia, Inc.
Orthopedic · 48d
Cleared Sep 25, 2015
Renovis Anterior Cervical Plate System
K152193
Renovis Surgical Technologies, Inc.
Orthopedic · 51d
Cleared Sep 24, 2015
Pyrenees Cervical Plate System
K152281
K2m
Orthopedic · 43d
Cleared Sep 04, 2015
Pyrenees Cervical Plate System
K152015
K2m, Inc.
Orthopedic · 45d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759
Degen Medical
Orthopedic · 127d
Cleared Jul 15, 2015
ACP 1 Anterior Cervical Plating System
K150700
Stryker Corporation
Orthopedic · 119d
Cleared Jul 14, 2015
Pyrenees Cervical Plate System
K150983
K2m
Orthopedic · 91d
Cleared Jul 10, 2015
Atrax Anterior Cervical Plating System
K150834
X-Spine Systems, Inc.
Orthopedic · 102d
Cleared Jul 01, 2015
CastleLoc-P Anterior Cervical Plate System
K143271
L & K Biomed Co., Ltd.
Orthopedic · 230d
Cleared Jul 01, 2015
ASFORA ANTERIOR CERVICAL PLATE SYSTEM
K143688
Medical Designs, LLC
Orthopedic · 189d
Cleared Jun 22, 2015
uNion Cervical Plate System
K150666
Ulrich Medical USA
Orthopedic · 98d
Cleared Jun 11, 2015
Captiva Spine SmartLOX Cervical Plate System
K141332
Captiva Spine
Orthopedic · 386d
Cleared May 29, 2015
Azure Anterior Cervical Plate System
K143028
Orthofix, Inc.
Orthopedic · 220d
Cleared May 07, 2015
Blue Mountain Cervical Plate System
K150036
Spineway
Orthopedic · 118d
Cleared May 01, 2015
Pyrenees Cervical Plate System
K142212
K2m, Inc.
Orthopedic · 262d
Cleared Apr 10, 2015
FortiBridge Anterior Cervical Plate System
K143706
Nanovis Spine, LLC
Orthopedic · 102d
Cleared Mar 20, 2015
LnK Anterior Cervical Plate System
K143279
L & K Biomed Co., Ltd.
Orthopedic · 126d
Cleared Mar 20, 2015
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
K143626
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Mar 20, 2015
LITe Plate System
K150449
Stryker Corp.
Orthopedic · 28d
Cleared Feb 27, 2015
Exactech Ambassador
K143576
Exactech, Inc.
Orthopedic · 72d