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
409–432 of 667
Cleared Feb 07, 2005
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K042073
Olsen Medical
Orthopedic · 189d
Cleared Feb 03, 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 01, 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782
Medtronic Sofamor Danek
Orthopedic · 602d
Cleared Feb 01, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151
Medtronic Sofamor Danek
Orthopedic · 78d
Cleared Dec 17, 2004
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K043181
Vertebron, Inc.
Orthopedic · 30d
Cleared Nov 24, 2004
KOBRA GPS FIXATION SYSTEM
K042859
Medtronic Vertelink, Inc.
Orthopedic · 40d
Cleared Nov 23, 2004
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544
Depuy Spine, Inc.
Orthopedic · 64d
Cleared Nov 23, 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082
Signus Medizintechnik GmbH
Orthopedic · 15d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 04, 2004
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
K042798
Interpore Cross Intl.
Orthopedic · 27d
Cleared Oct 07, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Sep 24, 2004
CERVICAL PLATE
K042317
Scient'X
Orthopedic · 29d
Cleared Sep 17, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 16, 2004
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
K041989
Sintea Biotech, Inc.
Orthopedic · 55d
Cleared Sep 08, 2004
LTD POLYAXIAL FIXATION SYSTEM
K041625
Us Spinal Technologies, LLC
Orthopedic · 85d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Aug 17, 2004
EXPEDIUM ANTERIOR SPINE SYSTEM
K041205
Depuy Spine, Inc.
Orthopedic · 102d
Cleared Aug 16, 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447
Nuvasive, Inc.
Orthopedic · 76d
Cleared Jul 30, 2004
ANTERIOR COMPACT SYSTEM
K041469
X-Spine Systems
Orthopedic · 58d
Cleared Jul 28, 2004
MACROPORE HYDROSORB SPINE SYSTEM
K041105
Macropore Biosurgery, Inc.
Orthopedic · 89d
Cleared Jul 19, 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794
Interpore Cross Intl.
Orthopedic · 17d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jun 02, 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655
Depuy Spine, Inc.
Orthopedic · 82d