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
Dec 24, 2013
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
Pioneer Surgical Technology, Inc.
Orthopedic
195d
Cleared
Dec 06, 2013
STAXX(R) SYSTEM
Spine Wave, Inc.
Orthopedic
49d
Cleared
Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
Medtronic Sofamor Danek, Inc.
Orthopedic
90d
Cleared
Sep 19, 2012
ENDURAMESH
Lucero Medical, LLC
Orthopedic
22d
Cleared
Aug 29, 2012
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
62d
Cleared
Aug 17, 2012
STGC
Cardinal Spine, LLC
Orthopedic
121d
Cleared
Jul 03, 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
Globus Medical, Inc.
Orthopedic
82d
Cleared
Apr 05, 2012
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
Choicespine, LP
Orthopedic
38d
Cleared
Jan 27, 2012
SANTORINI SPINAL SYSTEM
K2m, Inc.
Orthopedic
262d
Cleared
Jan 26, 2012
GIZA(R) VERTEBRAL BODY REPLACEMENT
Eden Spine, LLC
Orthopedic
156d
Cleared
Dec 13, 2011
STAXX(R) XD SYSTEM
Spine Wave, Inc.
Orthopedic
207d
Cleared
Oct 20, 2011
SYNTHES XRL
Synthes Spine Co.Lp
Orthopedic
342d
Cleared
Oct 12, 2011
SFC VERTEBRAL BODY REPLACEMENT
Konigsee Implantate GmbH
Orthopedic
266d
Cleared
Oct 07, 2011
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
Globus Medical, Inc.
Orthopedic
16d
Cleared
Aug 19, 2011
STAXX XDL SYSTEM
Spine Wave, Inc.
Orthopedic
368d
Cleared
Jul 19, 2011
STAXXSD SYSTEM
Spine Wave, Inc.
Orthopedic
53d
Cleared
Jun 15, 2011
BIOSPINE VBR SYSTEM
Aesculap Implant Systems, LLC
Orthopedic
78d
Cleared
Nov 30, 2010
STAXX(R) XD SYSTEM
Spine Wave, Inc.
Orthopedic
74d
Cleared
Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
Orthopedic
196d
Cleared
Sep 10, 2010
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
126d
Cleared
Mar 04, 2010
AESCULAP HYDROLIFT VBR SYSTEM
Aesculap Implant System, Inc.
Orthopedic
491d
Cleared
Oct 15, 2009
C-THRU SPINAL SYSTEM
Ebi, L.P.
Orthopedic
72d
Cleared
Oct 05, 2009
ADDPLUS
Ulrich GmbH & Co. KG
Orthopedic
192d
Cleared
Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
Stryker Spine
Orthopedic
87d