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 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 Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210
Nuvasive, Inc.
Orthopedic · 119d
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 Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
K052746
Depuy Spine, Inc.
Orthopedic · 21d
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 Jun 17, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196
Implex Corp.
Orthopedic · 38d
Cleared Jun 14, 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jun 09, 2005
BASIS VERTEBRAL BODY SPACER
K051105
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared May 27, 2005
PEEK CAS
K050861
Interpore Cross Intl.
Orthopedic · 52d
Cleared May 26, 2005
XPAND CORPECTOMY SPACER
K050850
Globus Medical, Inc.
Orthopedic · 52d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624
Stryker Spine
Orthopedic · 31d
Cleared Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571
Stryker Spine
Orthopedic · 143d
Cleared Feb 07, 2005
NUVASIVE COROENT SYSTEM
K043405
Nuvasive, Inc.
Orthopedic · 59d
Cleared Jan 21, 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206
Pioneer Surgical Technology
Orthopedic · 63d
Cleared Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Dec 29, 2004
TITANIUM MESH IMPLANT
K041407
Interpore Cross Intl.
Orthopedic · 216d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
K042268
Ebi, L.P.
Orthopedic · 65d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389
Synthes Spine
Orthopedic · 129d