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
Cleared
Nov 13, 2003
NUVASIVE MESH
Nuvasive, Inc.
Orthopedic
93d
Cleared
Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
Implex Corp.
Orthopedic
77d
Cleared
Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
Blackstone Medical, Inc.
Orthopedic
37d
Cleared
Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
Spinal Concepts, Inc.
Orthopedic
69d
Cleared
Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
50d
Cleared
Jul 12, 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
Spinal Concepts, Inc.
Orthopedic
22d
Cleared
Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
Implex Corp.
Orthopedic
28d
Cleared
Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
Blackstone Medical, Inc.
Orthopedic
109d
Cleared
Jun 27, 2003
SUSTAIN SPACER
Globus Medical, Inc.
Orthopedic
64d
Cleared
Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
Depuyacromed
Orthopedic
27d
Cleared
Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
39d
Cleared
Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
Depuyacromed
Orthopedic
24d
Cleared
Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
Medtronic Sofamor Danek
Orthopedic
23d
Cleared
Mar 25, 2003
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
28d
Cleared
Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
Synthes (Usa)
Orthopedic
76d
Cleared
Mar 04, 2003
NUVASIVE MASH
Nuvasive, Inc.
Orthopedic
151d
Cleared
Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
79d
Cleared
Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
Depuyacromed
Orthopedic
21d
Cleared
Jan 29, 2003
DEVEX MESH SYSTEM
Depuyacromed
Orthopedic
72d
Cleared
Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
Interpore Cross Intl.
Orthopedic
205d
Cleared
Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
26d
Cleared
Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
Implex Corp.
Orthopedic
28d
Cleared
Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
87d
Cleared
Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
Implex Corp.
Orthopedic
30d