MQP · Class II · 21 CFR 888.3060

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
49–72 of 279
Cleared Dec 24, 2013
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724
Pioneer Surgical Technology, Inc.
Orthopedic · 195d
Cleared Dec 06, 2013
STAXX(R) SYSTEM
K133207
Spine Wave, Inc.
Orthopedic · 49d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 19, 2012
ENDURAMESH
K122622
Lucero Medical, LLC
Orthopedic · 22d
Cleared Aug 29, 2012
STAXX XD SYSTEM
K121889
Spine Wave, Inc.
Orthopedic · 62d
Cleared Aug 17, 2012
STGC
K121176
Cardinal Spine, LLC
Orthopedic · 121d
Cleared Jul 03, 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107
Globus Medical, Inc.
Orthopedic · 82d
Cleared Apr 05, 2012
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
K120570
Choicespine, LP
Orthopedic · 38d
Cleared Jan 27, 2012
SANTORINI SPINAL SYSTEM
K111294
K2m, Inc.
Orthopedic · 262d
Cleared Jan 26, 2012
GIZA(R) VERTEBRAL BODY REPLACEMENT
K112429
Eden Spine, LLC
Orthopedic · 156d
Cleared Dec 13, 2011
STAXX(R) XD SYSTEM
K111418
Spine Wave, Inc.
Orthopedic · 207d
Cleared Oct 20, 2011
SYNTHES XRL
K103320
Synthes Spine Co.Lp
Orthopedic · 342d
Cleared Oct 12, 2011
SFC VERTEBRAL BODY REPLACEMENT
K110153
Konigsee Implantate GmbH
Orthopedic · 266d
Cleared Oct 07, 2011
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756
Globus Medical, Inc.
Orthopedic · 16d
Cleared Aug 19, 2011
STAXX XDL SYSTEM
K102315
Spine Wave, Inc.
Orthopedic · 368d
Cleared Jul 19, 2011
STAXXSD SYSTEM
K111469
Spine Wave, Inc.
Orthopedic · 53d
Cleared Jun 15, 2011
BIOSPINE VBR SYSTEM
K110864
Aesculap Implant Systems, LLC
Orthopedic · 78d
Cleared Nov 30, 2010
STAXX(R) XD SYSTEM
K102682
Spine Wave, Inc.
Orthopedic · 74d
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Sep 10, 2010
STAXX XD SYSTEM
K101288
Spine Wave, Inc.
Orthopedic · 126d
Cleared Mar 04, 2010
AESCULAP HYDROLIFT VBR SYSTEM
K083186
Aesculap Implant System, Inc.
Orthopedic · 491d
Cleared Oct 15, 2009
C-THRU SPINAL SYSTEM
K092336
Ebi, L.P.
Orthopedic · 72d
Cleared Oct 05, 2009
ADDPLUS
K090841
Ulrich GmbH & Co. KG
Orthopedic · 192d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946
Stryker Spine
Orthopedic · 87d