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., K2m, Inc. and Globus Medical, Inc..

667
Total
667
Cleared
111d
Avg days
1979
Since
667 devices
385–408 of 667
Cleared Nov 03, 1997
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730
Depuy, Inc.
Orthopedic · 178d
Cleared Nov 03, 1997
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060
Depuy, Inc.
Orthopedic · 77d
Cleared Oct 16, 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883
Synthes (Usa)
Orthopedic · 147d
Cleared Oct 01, 1997
M-2 ANTERIOR PLATE SYSTEM
K972718
Acromed Corp.
Orthopedic · 72d
Cleared Aug 01, 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048
Synthes (Usa)
Orthopedic · 207d
Cleared Jul 30, 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780
Sofamor Danek USA,Inc.
Orthopedic · 313d
Cleared Jun 11, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970955
Acromed Corp.
Orthopedic · 86d
Cleared Jun 11, 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248
Acromed Corp.
Orthopedic · 69d
Cleared May 02, 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Apr 03, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970462
Acromed Corp.
Orthopedic · 56d
Cleared Mar 17, 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K964416
Synthes (Usa)
Orthopedic · 164d
Cleared Mar 17, 1997
LIBERTY ANTERIOR SPINAL SYSTEM
K965193
Sofamor Danek USA,Inc.
Orthopedic · 83d
Cleared Feb 19, 1997
ANTERIOR DYNAMIZED SYSTEM
K953978
Acromed Corp.
Orthopedic · 546d
Cleared Feb 06, 1997
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
K964623
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Dec 27, 1996
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486
Depuy, Inc.
Orthopedic · 184d
Cleared Nov 27, 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655
Sofamor Danek USA,Inc.
Orthopedic · 76d
Cleared Nov 09, 1995
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730
Johnson & Johnson Professionals, Inc.
Orthopedic · 91d
Cleared Nov 02, 1995
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720
Aesculap, Inc.
Orthopedic · 85d
Cleared Aug 25, 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725
Synthes Spine
Orthopedic · 389d
Cleared Jul 20, 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700
Synthes (Usa)
Orthopedic · 246d
Cleared Feb 09, 1995
ISOLA ANTERIOR SYSTEM
K943819
Acromed Corp.
Orthopedic · 188d
Cleared Dec 19, 1994
ANTERIOR CERVIAL PLATING SYSTEM
K943523
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Nov 08, 1994
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756
Codman & Shurtleff, Inc.
Orthopedic · 399d
Cleared Oct 20, 1994
ANTERIOR SPINE SYSTEM
K934429
Buckman Co., Inc.
Orthopedic · 402d