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
217–240 of 667
Cleared Nov 05, 2010
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820
Alphatec Spine, Inc.
Orthopedic · 38d
Cleared Oct 14, 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848
Spinal Elements, Inc.
Orthopedic · 105d
Cleared Jul 21, 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255
Alphatec Spine, Inc.
Orthopedic · 78d
Cleared Jun 04, 2010
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K100708
Pioneer Surgical Technology
Orthopedic · 84d
Cleared May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614
Blackstone Medical, Inc.
Orthopedic · 61d
Cleared Mar 11, 2010
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
K092474
K2m, Inc.
Orthopedic · 211d
Cleared Feb 19, 2010
NUVASIVE HELIX REVOLUTION ACP SYSTEM
K093804
Nuvasive, Inc.
Orthopedic · 70d
Cleared Feb 12, 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K100061
K2m, Inc.
Orthopedic · 32d
Cleared Feb 04, 2010
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K100070
Depuy Spine, Inc.
Orthopedic · 24d
Cleared Jan 19, 2010
LIFE SPINE LUMBAR PLATE SYSTEM
K093200
Life Spine
Orthopedic · 102d
Cleared Nov 16, 2009
XTEND ANTERIOR CERVICAL PLATE SYSTEM
K092146
Globus Medical, Inc.
Orthopedic · 124d
Cleared Aug 13, 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jul 10, 2009
SYNTHES ORACLE PLATE
K091159
Synthes Spine
Orthopedic · 80d
Cleared Jun 04, 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
K091253
K2m, Inc.
Orthopedic · 36d
Cleared May 08, 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071
Nuvasive, Inc.
Orthopedic · 24d
Cleared Apr 28, 2009
PIONEER LUMBAR PLATE SYSTEM
K090222
Pioneer Surgical Technology
Orthopedic · 88d
Cleared Mar 26, 2009
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
K083020
Stryker Corp.
Orthopedic · 168d
Cleared Mar 25, 2009
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
K083562
Stryker Corp.
Orthopedic · 113d
Cleared Mar 20, 2009
NUVASIVE HELIX-T ACP SYSTEM
K083341
Nuvasive, Inc.
Orthopedic · 128d
Cleared Feb 25, 2009
PACP
K083663
Pioneer Surgical Technology
Orthopedic · 77d
Cleared Nov 19, 2008
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380
K2m, Inc.
Orthopedic · 187d
Cleared Nov 13, 2008
BIOMET ANTERIOR LUMBAR PLATE
K082187
Ebi, L.P.
Orthopedic · 101d
Cleared Sep 24, 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070
Nuvasive, Inc.
Orthopedic · 64d
Cleared Sep 10, 2008
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K082273
Depuy Spine, Inc.
Orthopedic · 30d