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 Aug 29, 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012
Zimmer Spine, Inc.
Orthopedic · 59d
Cleared Jun 04, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 85d
Cleared May 07, 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825
Orthofix, Inc.
Orthopedic · 42d
Cleared Apr 29, 2013
IRIS ANTERIOR CERVICAL PLATE
K130202
Life Spine, Inc.
Orthopedic · 91d
Cleared Feb 01, 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081
Nuvasive, Inc.
Orthopedic · 200d
Cleared Dec 28, 2012
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167
Medos International SARL
Orthopedic · 80d
Cleared Dec 14, 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514
Corelink, LLC
Orthopedic · 206d
Cleared Dec 07, 2012
V2F ANTERIOR FIXATION SYSTEM
K122733
Zimmer Spine, Inc.
Orthopedic · 92d
Cleared Nov 19, 2012
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791
Corelink, LLC
Orthopedic · 153d
Cleared Oct 23, 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815
Nuvasive, Inc.
Orthopedic · 125d
Cleared Oct 11, 2012
ARCHON ANTERIOR CERVICAL PLATE SYSTE,
K122910
Nu Vasive, Incorporated
Orthopedic · 20d
Cleared Jul 20, 2012
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
K121658
Orthofix, Inc.
Orthopedic · 45d
Cleared Jul 16, 2012
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837
Nuvasive, Inc.
Orthopedic · 24d
Cleared Jun 27, 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049
Globus Medical, Inc.
Orthopedic · 82d
Cleared Apr 13, 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092
Globus Medical, Inc.
Orthopedic · 93d
Cleared Jan 20, 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509
L & K Biomed Co., Ltd.
Orthopedic · 53d
Cleared Jan 17, 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329
K2m, Inc.
Orthopedic · 64d
Cleared Nov 21, 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724
Medos International SARL
Orthopedic · 63d
Cleared Oct 27, 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796
Zimmer Spine, Inc.
Orthopedic · 122d
Cleared Aug 17, 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135
K2m, Inc.
Orthopedic · 117d
Cleared Jul 22, 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jun 20, 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410
Nuvasive, Inc.
Orthopedic · 32d
Cleared Jun 01, 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423
Life Spine
Orthopedic · 191d
Cleared Mar 03, 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750
Nuvasive, Inc.
Orthopedic · 70d