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
25–48 of 279
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Nov 09, 2017
FORTIFY Corpectomy Spacers
K162315
Globus Medical, Inc.
Orthopedic · 448d
Cleared Mar 30, 2017
NuVasive(r) Monolith Corpectomy System
K170271
Nu Vasive, Incorporated
Orthopedic · 62d
Cleared Sep 04, 2015
NuVasive PEEK Corpectomy Railed System
K151538
Nu Vasive, Incorporated
Orthopedic · 88d
Cleared Sep 03, 2015
NuVasive PEEK Corpectomy System
K151167
Nu Vasive, Incorporated
Orthopedic · 125d
Cleared Feb 20, 2015
NuVasive X-CORE(R) Expandable VBR System
K142205
Nuvasive, Inc.
Orthopedic · 193d
Cleared Feb 19, 2015
StaXx(R) XD System
K142996
Spine Wave, Inc.
Orthopedic · 126d
Cleared Nov 06, 2014
CAPRI
K142016
K2m, Inc.
Orthopedic · 104d
Cleared Aug 07, 2014
LATERAL VBR SYSTEM
K140563
Nu Vasive, Incorporated
Orthopedic · 155d
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 Aug 29, 2012
STAXX XD SYSTEM
K121889
Spine Wave, Inc.
Orthopedic · 62d
Cleared Jul 03, 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107
Globus Medical, Inc.
Orthopedic · 82d
Cleared Jan 27, 2012
SANTORINI SPINAL SYSTEM
K111294
K2m, Inc.
Orthopedic · 262d
Cleared Dec 13, 2011
STAXX(R) XD SYSTEM
K111418
Spine Wave, Inc.
Orthopedic · 207d
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 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 Oct 15, 2009
C-THRU SPINAL SYSTEM
K092336
Ebi, L.P.
Orthopedic · 72d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946
Stryker Spine
Orthopedic · 87d
Cleared Sep 21, 2009
T2 SPINAL SYSTEM
K091883
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d