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., Globus Medical, Inc. and K2m, Inc..

667
Total
667
Cleared
111d
Avg days
1979
Since
667 devices
361–384 of 667
Cleared Feb 18, 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122
Danek Medical, Inc.
Orthopedic · 73d
Cleared Dec 29, 1999
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030
Depuyacromed
Orthopedic · 113d
Cleared Dec 27, 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959
Spineology, Inc.
Orthopedic · 280d
Cleared Dec 15, 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855
Danek Medical, Inc.
Orthopedic · 30d
Cleared Dec 10, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822
Ebi, L.P.
Orthopedic · 28d
Cleared Nov 16, 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784
United States Surgical, A Division of Tyco Healthc
Orthopedic · 69d
Cleared Oct 22, 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Sep 23, 1999
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168
Depuyacromed
Orthopedic · 87d
Cleared Jul 30, 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Mar 25, 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798
Osteonics Corp.
Orthopedic · 227d
Cleared Mar 10, 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603
Danek Medical, Inc.
Orthopedic · 15d
Cleared Feb 24, 1999
XIA SPINE SYSTEM
K984251
Howmedica, Inc.
Orthopedic · 89d
Cleared Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875
Danek Medical, Inc.
Orthopedic · 158d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342
United States Surgical, A Division of Tyco Healthc
Orthopedic · 26d
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899
United States Surgical, A Division of Tyco Healthc
Orthopedic · 49d
Cleared Jun 17, 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885
Blackstone Medical, Inc.
Orthopedic · 169d
Cleared Apr 14, 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228
Acromed Corp.
Orthopedic · 82d
Cleared Mar 16, 1998
ORION ANTERIOR CERVICAL PLATE SYSTEM
K973854
Sofamor Danek USA,Inc.
Orthopedic · 164d
Cleared Mar 13, 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706
Aesculap, Inc.
Orthopedic · 87d
Cleared Mar 05, 1998
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
K974757
Acromed Corp.
Orthopedic · 76d
Cleared Mar 02, 1998
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
K974525
Synthes Spine
Orthopedic · 90d
Cleared Feb 19, 1998
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
K974435
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Nov 03, 1997
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730
Depuy, Inc.
Orthopedic · 178d