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 Interpore Cross Intl..

279
Total
279
Cleared
114d
Avg days
1999
Since
279 devices
97–120 of 279
Cleared Jun 28, 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786
Theken Spine, LLC
Orthopedic · 98d
Cleared Jun 25, 2007
SMALL STATURE SPACERS
K063393
Biomet Spine
Orthopedic · 228d
Cleared Apr 25, 2007
THEKEN VU MESH VBR SYSTEM
K070381
Theken Spine, LLC
Orthopedic · 76d
Cleared Apr 03, 2007
SYNFIX -LR
K062083
Synthes Spine Co.Lp
Orthopedic · 256d
Cleared Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
K070173
Medtronic Sofamor Danek, Inc.
Orthopedic · 55d
Cleared Mar 09, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063464
Atlas Spine, Inc.
Orthopedic · 113d
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 31, 2007
SYNTHES ORACLE SPACER
K062933
Synthes Spine Co.Lp
Orthopedic · 125d
Cleared Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666
Ortho Development Corp.
Orthopedic · 140d
Cleared Dec 26, 2006
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
K060416
Ulrich GmbH & Co. KG
Orthopedic · 312d
Cleared Dec 22, 2006
BOX PEEK VBR SYSTEM
K062151
Innovasis, Inc.
Orthopedic · 148d
Cleared Dec 18, 2006
MOBIS SPINAL IMPLANT
K061082
Signus Medizintechnik GmbH
Orthopedic · 244d
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 18, 2006
SYNEX II
K061891
Synthes Spine Co.Lp
Orthopedic · 46d
Cleared Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
K062132
Stryker Spine
Orthopedic · 21d
Cleared Aug 15, 2006
SPINAL USA VBR SYSTEM
K061752
Spinal USA
Orthopedic · 55d
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