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
Cleared
Sep 21, 2009
T2 SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
Orthopedic
89d
Cleared
Sep 03, 2009
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
206d
Cleared
Apr 27, 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
Nuvasive, Inc.
Orthopedic
94d
Cleared
Feb 12, 2009
LDR SPINE ROI-C IMPLANT
Ldr Spine USA
Orthopedic
50d
Cleared
Aug 27, 2008
T2 XVBR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
30d
Cleared
Jul 02, 2008
RELIANCE VBS SYSTEM
Reliance Medical Systems, LLC
Orthopedic
47d
Cleared
Jun 10, 2008
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
Signus Medizintechnik GmbH
Orthopedic
29d
Cleared
May 29, 2008
LDR SPINE ROI-C IMPLANT
Ldr Spine USA
Orthopedic
76d
Cleared
May 21, 2008
NOVEL SPINAL SPACER SYSTEM
Alphatec Spine, Inc.
Orthopedic
70d
Cleared
May 07, 2008
LDR SPINE ROI-T IMPLANT
Ldr Spine USA
Orthopedic
68d
Cleared
May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
Depuy Spine, Inc.
Orthopedic
62d
Cleared
Apr 07, 2008
LDR SPINE ROI-A IMPLANT
Ldr Spine USA
Orthopedic
38d
Cleared
Mar 10, 2008
KIMBA MINI
Signus Medizintechnik GmbH
Orthopedic
28d
Cleared
Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
Depuy Spine, Inc.
Orthopedic
30d
Cleared
Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K2m, Inc.
Orthopedic
20d
Cleared
Jan 09, 2008
MODIFICATION TO VALEO VBR
Amedica Corp.
Orthopedic
27d
Cleared
Dec 05, 2007
VALEO VBR
Amedica Corp.
Orthopedic
29d
Cleared
Oct 23, 2007
ZUMA
Seaspine, Inc.
Orthopedic
120d
Cleared
Oct 04, 2007
NIKO CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
30d
Cleared
Sep 27, 2007
RELIANCE VBS SYSTEM
Reliance Medical Systems, LLC
Orthopedic
294d
Cleared
Aug 30, 2007
LDR SPINE ROI-T SYSTEM
Ldr Spine USA
Orthopedic
28d
Cleared
Aug 14, 2007
T2 XVBR SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
124d
Cleared
Jul 30, 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
Theken Spine, LLC
Orthopedic
110d
Cleared
Jun 29, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Atlas Spine, Inc.
Orthopedic
29d