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 03, 2009
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
206d
Cleared
Apr 27, 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
Nuvasive, Inc.
Orthopedic
94d
Cleared
Aug 27, 2008
T2 XVBR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
30d
Cleared
May 21, 2008
NOVEL SPINAL SPACER SYSTEM
Alphatec Spine, Inc.
Orthopedic
70d
Cleared
May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
Depuy Spine, Inc.
Orthopedic
62d
Cleared
Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
Depuy Spine, Inc.
Orthopedic
30d
Cleared
Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K2m, Inc.
Orthopedic
20d
Cleared
Oct 04, 2007
NIKO CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
30d
Cleared
Aug 14, 2007
T2 XVBR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
124d
Cleared
Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
55d
Cleared
Mar 05, 2007
T2 SCEPTOR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
108d
Cleared
Feb 23, 2007
ALEUTIAN SPACER SYSTEM
K2m, Inc.
Orthopedic
106d
Cleared
Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
Ortho Development Corp.
Orthopedic
140d
Cleared
Oct 17, 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
Ebi, L.P.
Orthopedic
28d
Cleared
Sep 14, 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
Aesculap, Inc.
Orthopedic
177d
Cleared
Sep 12, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
25d
Cleared
Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
Stryker Spine
Orthopedic
21d
Cleared
Aug 14, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
24d
Cleared
Aug 09, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
30d
Cleared
Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
Stryker Spine
Orthopedic
35d
Cleared
Jul 24, 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
Pioneer Surgical Technology
Orthopedic
90d
Cleared
Jun 08, 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
Ebi, L.P.
Orthopedic
56d
Cleared
Jun 08, 2006
RETAIN RADIOLUCENT SPACER
Globus Medical, Inc.
Orthopedic
21d
Cleared
May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
Stryker Spine
Orthopedic
87d