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
169–192 of 667
Cleared Jul 15, 2015
ACP 1 Anterior Cervical Plating System
K150700
Stryker Corporation
Orthopedic · 119d
Cleared Jul 01, 2015
CastleLoc-P Anterior Cervical Plate System
K143271
L & K Biomed Co., Ltd.
Orthopedic · 230d
Cleared May 29, 2015
Azure Anterior Cervical Plate System
K143028
Orthofix, Inc.
Orthopedic · 220d
Cleared May 01, 2015
Pyrenees Cervical Plate System
K142212
K2m, Inc.
Orthopedic · 262d
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
Cleared Jan 26, 2015
Aviator Anterior Cervical Plate (ACP) System
K142237
Stryker Corporation
Orthopedic · 166d
Cleared Jan 21, 2015
NuVasive ALIF Buttress Plate System
K143065
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Dec 31, 2014
LITe Plate System
K142699
Stryker Corporation
Orthopedic · 100d
Cleared Dec 04, 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 169d
Cleared Sep 23, 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500
Zimmer Spine, Inc.
Orthopedic · 109d
Cleared Jul 09, 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417
Medtronic Sofamor Danek, Inc.
Orthopedic · 141d
Cleared Jul 02, 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260
Orthofix, Inc.
Orthopedic · 149d
Cleared Jun 12, 2014
META-C CERVICAL PLATE
K140361
Medacta International
Orthopedic · 120d
Cleared May 21, 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611
Zimmer Spine, Inc.
Orthopedic · 72d
Cleared Feb 20, 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567
Globus Medical, Inc.
Orthopedic · 92d
Cleared Dec 05, 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994
Corelink, LLC
Orthopedic · 72d
Cleared Nov 27, 2013
ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025
Nuvasive, Inc.
Orthopedic · 229d
Cleared Nov 09, 2013
CAYMAN MI PLATE SYSTEM
K131533
K2m, Inc.
Orthopedic · 168d
Cleared Oct 08, 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589
Life Spine, Inc.
Orthopedic · 50d
Cleared Sep 06, 2013
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
K132324
Medos International SARL
Orthopedic · 42d
Cleared Aug 29, 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868
Nuvasive, Inc.
Orthopedic · 153d