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 Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059
Aesculap, Inc.
Orthopedic · 23d
Cleared Jul 02, 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276
Synthes (Usa)
Orthopedic · 71d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667
Encore Medical, L.P.
Orthopedic · 86d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 18, 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866
Synthes (Usa)
Orthopedic · 30d
Cleared Mar 28, 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965
Blackstone Medical, Inc.
Orthopedic · 203d
Cleared Feb 26, 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Dec 11, 2002
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039
Depuyacromed
Orthopedic · 254d
Cleared Nov 19, 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
K022798
Corin USA
Orthopedic · 88d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791
Synthes (Usa)
Orthopedic · 83d
Cleared Oct 18, 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133
Ebi, L.P.
Orthopedic · 28d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Aug 21, 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605
Blackstone Medical, Inc.
Orthopedic · 15d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Jul 22, 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared May 23, 2002
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020620
Blackstone Medical, Inc.
Orthopedic · 87d
Cleared May 22, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020600
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared May 13, 2002
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K021226
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244
Synthes Spine
Orthopedic · 88d
Cleared Apr 05, 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649
Ortho Development Corp.
Orthopedic · 36d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d