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
Sep 23, 2004
MODIFICATION TO VBR SPINAL SYSTEM
Depuy Spine, Inc.
Orthopedic
91d
Cleared
Aug 27, 2004
EXPANDABLE PEEK VBR IMPLANT
Interpore Cross Intl.
Orthopedic
140d
Cleared
Aug 17, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
Blackstone Medical, Inc.
Orthopedic
29d
Cleared
Aug 09, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
94d
Cleared
Aug 05, 2004
STRYKER SPINE VERTEBRAL SPACER
Stryker Spine
Orthopedic
136d
Cleared
Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
Medtronic Sofamor Danek
Orthopedic
202d
Cleared
Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
21d
Cleared
Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
23d
Cleared
May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
64d
Cleared
Apr 16, 2004
EBI ESL SPINE SPACER SYSTEM
Ebi, L.P.
Orthopedic
51d
Cleared
Apr 08, 2004
MODIFICATION TO GEO STRUCTURE
Interpore Cross Intl.
Orthopedic
73d
Cleared
Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
Blackstone Medical, Inc.
Orthopedic
127d
Cleared
Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
Globus Medical, Inc.
Orthopedic
46d
Cleared
Mar 19, 2004
MODIFICATION TO VERTE-STACK
Medtronic Sofamor Danek
Orthopedic
30d
Cleared
Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
23d
Cleared
Feb 12, 2004
TITANIUM MESH SYSTEM
Encore Medical, L.P.
Orthopedic
195d
Cleared
Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
Howmedica Osteonics Corp.
Orthopedic
29d
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
Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
50d
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