MQP · Class II · 21 CFR 888.3060

FDA Product Code MQP: Spinal Vertebral Body Replacement Device

FDA product code MQP covers spinal vertebral body replacement devices used to reconstruct the anterior column of the spine.

These expandable or fixed-height titanium or PEEK cages are used to replace one or more vertebral bodies removed due to tumor, infection, trauma, or deformity, restoring anterior column support and spinal alignment while facilitating fusion.

MQP devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Medtronic Sofamor Danek, Globus Medical, Inc. and Spine Wave, Inc..

279
Total
279
Cleared
114d
Avg days
1999
Since
279 devices
121–144 of 279
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635
Depuyacromed
Orthopedic · 27d
Cleared Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735
Medtronic Sofamor Danek
Orthopedic · 39d
Cleared Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
K030833
Depuyacromed
Orthopedic · 24d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Mar 25, 2003
VERTE-STACK SPINAL SYSTEM
K030601
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364
Synthes (Usa)
Orthopedic · 76d
Cleared Mar 04, 2003
NUVASIVE MASH
K023319
Nuvasive, Inc.
Orthopedic · 151d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
K030249
Depuyacromed
Orthopedic · 21d
Cleared Jan 29, 2003
DEVEX MESH SYSTEM
K023835
Depuyacromed
Orthopedic · 72d
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143
Interpore Cross Intl.
Orthopedic · 205d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563
Implex Corp.
Orthopedic · 28d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967
Implex Corp.
Orthopedic · 30d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037
Synthes (Usa)
Orthopedic · 452d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025
Implex Corp.
Orthopedic · 52d
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887
Ebi, L.P.
Orthopedic · 59d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152
Synthes (Usa)
Orthopedic · 89d
Cleared Mar 21, 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522
Depuyacromed
Orthopedic · 30d
Cleared Feb 21, 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
K020204
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378
Implex Corp.
Orthopedic · 354d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145
Interpore Cross Intl.
Orthopedic · 30d