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
73–96 of 279
Cleared Sep 21, 2009
T2 SPINAL SYSTEM
K091883
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
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 Feb 12, 2009
LDR SPINE ROI-C IMPLANT
K083857
Ldr Spine USA
Orthopedic · 50d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Jul 02, 2008
RELIANCE VBS SYSTEM
K081383
Reliance Medical Systems, LLC
Orthopedic · 47d
Cleared Jun 10, 2008
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
K081332
Signus Medizintechnik GmbH
Orthopedic · 29d
Cleared May 29, 2008
LDR SPINE ROI-C IMPLANT
K080728
Ldr Spine USA
Orthopedic · 76d
Cleared May 21, 2008
NOVEL SPINAL SPACER SYSTEM
K080699
Alphatec Spine, Inc.
Orthopedic · 70d
Cleared May 07, 2008
LDR SPINE ROI-T IMPLANT
K080569
Ldr Spine USA
Orthopedic · 68d
Cleared May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568
Depuy Spine, Inc.
Orthopedic · 62d
Cleared Apr 07, 2008
LDR SPINE ROI-A IMPLANT
K080572
Ldr Spine USA
Orthopedic · 38d
Cleared Mar 10, 2008
KIMBA MINI
K080349
Signus Medizintechnik GmbH
Orthopedic · 28d
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 Jan 09, 2008
MODIFICATION TO VALEO VBR
K073505
Amedica Corp.
Orthopedic · 27d
Cleared Dec 05, 2007
VALEO VBR
K073125
Amedica Corp.
Orthopedic · 29d
Cleared Oct 23, 2007
ZUMA
K071726
Seaspine, Inc.
Orthopedic · 120d
Cleared Oct 04, 2007
NIKO CORPECTOMY SPACER
K072465
Globus Medical, Inc.
Orthopedic · 30d
Cleared Sep 27, 2007
RELIANCE VBS SYSTEM
K063637
Reliance Medical Systems, LLC
Orthopedic · 294d
Cleared Aug 30, 2007
LDR SPINE ROI-T SYSTEM
K072132
Ldr Spine USA
Orthopedic · 28d
Cleared Aug 14, 2007
T2 XVBR SPINAL SYSTEM
K071033
Medtronic Sofamor Danek
Orthopedic · 124d
Cleared Jul 30, 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031
Theken Spine, LLC
Orthopedic · 110d
Cleared Jun 29, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497
Atlas Spine, Inc.
Orthopedic · 29d