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
457–480 of 667
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791
Synthes (Usa)
Orthopedic · 83d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564
Spinal Concepts, Inc.
Orthopedic · 165d
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 Feb 13, 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979
Spinal Concepts, Inc.
Orthopedic · 72d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107
Endius, Inc.
Orthopedic · 62d
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
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556
Aesculap, Inc.
Orthopedic · 179d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824
Aesculap, Inc.
Orthopedic · 239d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115
Howmedica Osteonics Corp.
Orthopedic · 90d