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
May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
57d
Cleared
Apr 27, 2006
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
212d
Cleared
Apr 14, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
28d
Cleared
Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
Blackstone Medical, Inc.
Orthopedic
14d
Cleared
Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
Nuvasive, Inc.
Orthopedic
119d
Cleared
Nov 16, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
28d
Cleared
Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
Stryker Spine
Orthopedic
177d
Cleared
Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
Depuy Spine, Inc.
Orthopedic
21d
Cleared
Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
Orthopedic
49d
Cleared
Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
Implex Corp.
Orthopedic
64d
Cleared
Jun 17, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
Implex Corp.
Orthopedic
38d
Cleared
Jun 14, 2005
CONSTRUX MINI PEEK VBR SYSTEM
Blackstone Medical, Inc.
Orthopedic
29d
Cleared
Jun 09, 2005
BASIS VERTEBRAL BODY SPACER
Medtronic Sofamor Danek
Orthopedic
38d
Cleared
May 27, 2005
PEEK CAS
Interpore Cross Intl.
Orthopedic
52d
Cleared
May 26, 2005
XPAND CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
52d
Cleared
Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
Stryker Spine
Orthopedic
31d
Cleared
Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
Stryker Spine
Orthopedic
143d
Cleared
Feb 07, 2005
NUVASIVE COROENT SYSTEM
Nuvasive, Inc.
Orthopedic
59d
Cleared
Jan 21, 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
Pioneer Surgical Technology
Orthopedic
63d
Cleared
Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
11d
Cleared
Dec 29, 2004
TITANIUM MESH IMPLANT
Interpore Cross Intl.
Orthopedic
216d
Cleared
Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
2d
Cleared
Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
Ebi, L.P.
Orthopedic
65d
Cleared
Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
Synthes Spine
Orthopedic
129d