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
Jun 08, 2006
RETAIN RADIOLUCENT SPACER
Globus Medical, Inc.
Orthopedic
21d
Cleared
May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
Stryker Spine
Orthopedic
87d
Cleared
May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
Globus Medical, Inc.
Orthopedic
57d
Cleared
Apr 27, 2006
STAXX XD SYSTEM
Spine Wave, Inc.
Orthopedic
212d
Cleared
Apr 14, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
28d
Cleared
Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
Blackstone Medical, Inc.
Orthopedic
14d
Cleared
Feb 17, 2006
ARX SPINAL SYSTEM
Amedica Corp.
Orthopedic
254d
Cleared
Feb 13, 2006
SYNFIX-LR
Synthes Spine Co.Lp
Orthopedic
59d
Cleared
Dec 21, 2005
SEASPINE VBR SYSTEM
Seaspine, Inc.
Orthopedic
134d
Cleared
Dec 16, 2005
GRAFTCAGE TLX
Osteotech, Inc.
Orthopedic
168d
Cleared
Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
Nuvasive, Inc.
Orthopedic
119d
Cleared
Dec 01, 2005
GRAFTCAGE ACX
Osteotech, Inc.
Orthopedic
29d
Cleared
Nov 16, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
Orthopedic
28d
Cleared
Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
Stryker Spine
Orthopedic
177d
Cleared
Nov 03, 2005
KIMBA SPINAL IMPLANT
Signus Medizintechnik GmbH
Orthopedic
49d
Cleared
Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
Depuy Spine, Inc.
Orthopedic
21d
Cleared
Oct 07, 2005
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
Flexuspine, Inc.
Orthopedic
170d
Cleared
Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
Orthopedic
49d
Cleared
Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
Implex Corp.
Orthopedic
64d
Cleared
Jul 27, 2005
ALEUTIAN SPACER SYSTEM
K2m, LLC
Orthopedic
55d
Cleared
Jul 13, 2005
SEMIAL SPINAL IMPLANT
Signus Medizintechnik GmbH
Orthopedic
21d
Cleared
Jul 07, 2005
QUANTUM VERTEBRAL BODY REPLACEMENT
Quantum Orthopedics, Inc.
Orthopedic
135d
Cleared
Jun 30, 2005
MC+ PARTIAL VBR
Ldr Spine USA
Orthopedic
196d
Cleared
Jun 29, 2005
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
Ldr Spine USA
Orthopedic
205d