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 Sep 03, 2009
STAXX XD SYSTEM
K090315
Spine Wave, Inc.
Orthopedic · 206d
Cleared Apr 27, 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176
Nuvasive, Inc.
Orthopedic · 94d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared May 21, 2008
NOVEL SPINAL SPACER SYSTEM
K080699
Alphatec Spine, Inc.
Orthopedic · 70d
Cleared May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568
Depuy Spine, Inc.
Orthopedic · 62d
Cleared Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
K073649
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024
K2m, Inc.
Orthopedic · 20d
Cleared Oct 04, 2007
NIKO CORPECTOMY SPACER
K072465
Globus Medical, Inc.
Orthopedic · 30d
Cleared Aug 14, 2007
T2 XVBR SPINAL SYSTEM
K071033
Medtronic Sofamor Danek
Orthopedic · 124d
Cleared Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
K070173
Medtronic Sofamor Danek, Inc.
Orthopedic · 55d
Cleared Mar 05, 2007
T2 SCEPTOR SPINAL SYSTEM
K063491
Medtronic Sofamor Danek
Orthopedic · 108d
Cleared Feb 23, 2007
ALEUTIAN SPACER SYSTEM
K063399
K2m, Inc.
Orthopedic · 106d
Cleared Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666
Ortho Development Corp.
Orthopedic · 140d
Cleared Oct 17, 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810
Ebi, L.P.
Orthopedic · 28d
Cleared Sep 14, 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762
Aesculap, Inc.
Orthopedic · 177d
Cleared Sep 12, 2006
VERTE-STACK SPINAL SYSTEM
K062427
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
K062132
Stryker Spine
Orthopedic · 21d
Cleared Aug 14, 2006
VERTE-STACK SPINAL SYSTEM
K062073
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Aug 09, 2006
VERTE-STACK SPINAL SYSTEM
K061938
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
K061836
Stryker Spine
Orthopedic · 35d
Cleared Jul 24, 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
K061151
Pioneer Surgical Technology
Orthopedic · 90d
Cleared Jun 08, 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016
Ebi, L.P.
Orthopedic · 56d
Cleared Jun 08, 2006
RETAIN RADIOLUCENT SPACER
K061380
Globus Medical, Inc.
Orthopedic · 21d
Cleared May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506
Stryker Spine
Orthopedic · 87d