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
121–144 of 279
Cleared Jun 08, 2006
RETAIN RADIOLUCENT SPACER
K061380
Globus Medical, Inc.
Orthopedic · 21d
Cleared May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506
Stryker Spine
Orthopedic · 87d
Cleared May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665
Globus Medical, Inc.
Orthopedic · 57d
Cleared Apr 27, 2006
STAXX XD SYSTEM
K052670
Spine Wave, Inc.
Orthopedic · 212d
Cleared Apr 14, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Feb 17, 2006
ARX SPINAL SYSTEM
K051525
Amedica Corp.
Orthopedic · 254d
Cleared Feb 13, 2006
SYNFIX-LR
K053508
Synthes Spine Co.Lp
Orthopedic · 59d
Cleared Dec 21, 2005
SEASPINE VBR SYSTEM
K052170
Seaspine, Inc.
Orthopedic · 134d
Cleared Dec 16, 2005
GRAFTCAGE TLX
K051781
Osteotech, Inc.
Orthopedic · 168d
Cleared Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210
Nuvasive, Inc.
Orthopedic · 119d
Cleared Dec 01, 2005
GRAFTCAGE ACX
K053080
Osteotech, Inc.
Orthopedic · 29d
Cleared Nov 16, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205
Stryker Spine
Orthopedic · 177d
Cleared Nov 03, 2005
KIMBA SPINAL IMPLANT
K052533
Signus Medizintechnik GmbH
Orthopedic · 49d
Cleared Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
K052746
Depuy Spine, Inc.
Orthopedic · 21d
Cleared Oct 07, 2005
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
K050997
Flexuspine, Inc.
Orthopedic · 170d
Cleared Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978
Implex Corp.
Orthopedic · 64d
Cleared Jul 27, 2005
ALEUTIAN SPACER SYSTEM
K051454
K2m, LLC
Orthopedic · 55d
Cleared Jul 13, 2005
SEMIAL SPINAL IMPLANT
K051659
Signus Medizintechnik GmbH
Orthopedic · 21d
Cleared Jul 07, 2005
QUANTUM VERTEBRAL BODY REPLACEMENT
K050449
Quantum Orthopedics, Inc.
Orthopedic · 135d
Cleared Jun 30, 2005
MC+ PARTIAL VBR
K043479
Ldr Spine USA
Orthopedic · 196d
Cleared Jun 29, 2005
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
K043349
Ldr Spine USA
Orthopedic · 205d