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
Jun 29, 2005
STALIF TT
Surgicraft , Ltd.
Orthopedic
68d
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
CO VERTEBRAL BODY REPLACEMENT
Scient'X
Orthopedic
105d
Cleared
May 27, 2005
PEEK CAS
Interpore Cross Intl.
Orthopedic
52d
Cleared
May 26, 2005
XPAND CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
52d
Cleared
May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
Spinal Concepts, Inc.
Orthopedic
29d
Cleared
May 17, 2005
THEKEN REVEAL VBR SYSTEM
Theken Surgical,Llc
Orthopedic
126d
Cleared
Apr 18, 2005
NOVEL VBR SPINAL SYSTEM
Alphatec/Nexmed
Orthopedic
46d
Cleared
Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
Stryker Spine
Orthopedic
31d
Cleared
Feb 18, 2005
STANSION MATRIX
Spineworks, LLC
Orthopedic
148d
Cleared
Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
Stryker Spine
Orthopedic
143d
Cleared
Feb 07, 2005
ATALIA TITANIUM SURGICAL MESH
Us Spinal Technologies, LLC
Orthopedic
220d
Cleared
Feb 07, 2005
RABEA SPINAL IMPLANT
Signus Medizintechnik GmbH
Orthopedic
67d
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
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
Spine Next America Corporation
Orthopedic
90d
Cleared
Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
Spine Next America Corporation
Orthopedic
96d
Cleared
Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
2d
Cleared
Dec 28, 2004
SPACEVISION CAGE SYSTEM
Spine Vision, Inc.
Orthopedic
67d
Cleared
Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
Ebi, L.P.
Orthopedic
65d