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
145–168 of 279
Cleared Jun 29, 2005
STALIF TT
K051027
Surgicraft , Ltd.
Orthopedic · 68d
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
CO VERTEBRAL BODY REPLACEMENT
K050348
Scient'X
Orthopedic · 105d
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 May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared May 17, 2005
THEKEN REVEAL VBR SYSTEM
K050058
Theken Surgical,Llc
Orthopedic · 126d
Cleared Apr 18, 2005
NOVEL VBR SPINAL SYSTEM
K050553
Alphatec/Nexmed
Orthopedic · 46d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624
Stryker Spine
Orthopedic · 31d
Cleared Feb 18, 2005
STANSION MATRIX
K042600
Spineworks, LLC
Orthopedic · 148d
Cleared Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571
Stryker Spine
Orthopedic · 143d
Cleared Feb 07, 2005
ATALIA TITANIUM SURGICAL MESH
K041798
Us Spinal Technologies, LLC
Orthopedic · 220d
Cleared Feb 07, 2005
RABEA SPINAL IMPLANT
K043316
Signus Medizintechnik GmbH
Orthopedic · 67d
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
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713
Spine Next America Corporation
Orthopedic · 90d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
K042714
Spine Next America Corporation
Orthopedic · 96d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Dec 28, 2004
SPACEVISION CAGE SYSTEM
K042930
Spine Vision, Inc.
Orthopedic · 67d
Cleared Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
K042268
Ebi, L.P.
Orthopedic · 65d