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
313–336 of 667
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 22, 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360
X-Spine Systems, Inc.
Orthopedic · 171d
Cleared Jan 19, 2010
LIFE SPINE LUMBAR PLATE SYSTEM
K093200
Life Spine
Orthopedic · 102d
Cleared Dec 22, 2009
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K091926
Choicespine, LP
Orthopedic · 175d
Cleared Nov 17, 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659
Spinal USA
Orthopedic · 81d
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 Jul 09, 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044
Spinal USA
Orthopedic · 87d
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 Apr 07, 2009
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
K090316
Lanx, Inc.
Orthopedic · 57d
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 Feb 02, 2009
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K083338
Seaspine, Inc.
Orthopedic · 82d
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 26, 2008
SEEPLATE CERVICAL PLATE SYSTEM
K082037
Amedica Corp.
Orthopedic · 71d
Cleared Sep 24, 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070
Nuvasive, Inc.
Orthopedic · 64d