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
193–216 of 279
Cleared Nov 13, 2003
NUVASIVE MESH
K032476
Nuvasive, Inc.
Orthopedic · 93d
Cleared Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527
Implex Corp.
Orthopedic · 77d
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700
Blackstone Medical, Inc.
Orthopedic · 37d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
K031780
Medtronic Sofamor Danek
Orthopedic · 50d
Cleared Jul 12, 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914
Spinal Concepts, Inc.
Orthopedic · 22d
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823
Implex Corp.
Orthopedic · 28d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302
Globus Medical, Inc.
Orthopedic · 64d
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