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
Cleared
Jun 28, 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
Theken Spine, LLC
Orthopedic
98d
Cleared
Jun 25, 2007
SMALL STATURE SPACERS
Biomet Spine
Orthopedic
228d
Cleared
Apr 25, 2007
THEKEN VU MESH VBR SYSTEM
Theken Spine, LLC
Orthopedic
76d
Cleared
Apr 03, 2007
SYNFIX -LR
Synthes Spine Co.Lp
Orthopedic
256d
Cleared
Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
55d
Cleared
Mar 09, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Atlas Spine, Inc.
Orthopedic
113d
Cleared
Mar 05, 2007
T2 SCEPTOR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
108d
Cleared
Feb 23, 2007
ALEUTIAN SPACER SYSTEM
K2m, Inc.
Orthopedic
106d
Cleared
Jan 31, 2007
SYNTHES ORACLE SPACER
Synthes Spine Co.Lp
Orthopedic
125d
Cleared
Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
Ortho Development Corp.
Orthopedic
140d
Cleared
Dec 26, 2006
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
Ulrich GmbH & Co. KG
Orthopedic
312d
Cleared
Dec 22, 2006
BOX PEEK VBR SYSTEM
Innovasis, Inc.
Orthopedic
148d
Cleared
Dec 18, 2006
MOBIS SPINAL IMPLANT
Signus Medizintechnik GmbH
Orthopedic
244d
Cleared
Oct 17, 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
Ebi, L.P.
Orthopedic
28d
Cleared
Sep 14, 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
Aesculap, Inc.
Orthopedic
177d
Cleared
Sep 12, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
25d
Cleared
Aug 18, 2006
SYNEX II
Synthes Spine Co.Lp
Orthopedic
46d
Cleared
Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
Stryker Spine
Orthopedic
21d
Cleared
Aug 15, 2006
SPINAL USA VBR SYSTEM
Spinal USA
Orthopedic
55d
Cleared
Aug 14, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
24d
Cleared
Aug 09, 2006
VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
30d
Cleared
Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
Stryker Spine
Orthopedic
35d
Cleared
Jul 24, 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
Pioneer Surgical Technology
Orthopedic
90d
Cleared
Jun 08, 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
Ebi, L.P.
Orthopedic
56d