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 Interpore Cross Intl..

279
Total
279
Cleared
114d
Avg days
1999
Since
279 devices
169–192 of 279
Cleared Oct 07, 2004
NOVEL VBR SPINAL SYSTEM
K042201
Alphatec/Nexmed
Orthopedic · 55d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389
Synthes Spine
Orthopedic · 129d
Cleared Sep 23, 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Sep 08, 2004
STALIF TT
K041617
Surgicraft , Ltd.
Orthopedic · 85d
Cleared Aug 27, 2004
EXPANDABLE PEEK VBR IMPLANT
K040928
Interpore Cross Intl.
Orthopedic · 140d
Cleared Aug 17, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Aug 10, 2004
CURVED PEEK TETRIS SPINAL IMPLANT
K041888
Signus Medizintechnik GmbH
Orthopedic · 29d
Cleared Aug 09, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Aug 05, 2004
STRYKER SPINE VERTEBRAL SPACER
K040731
Stryker Spine
Orthopedic · 136d
Cleared Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared May 27, 2004
SPINAL CONCEPTS INC. CODA
K033663
Spinal Concepts, Inc.
Orthopedic · 188d
Cleared May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Apr 16, 2004
EBI ESL SPINE SPACER SYSTEM
K040482
Ebi, L.P.
Orthopedic · 51d
Cleared Apr 08, 2004
MODIFICATION TO GEO STRUCTURE
K040168
Interpore Cross Intl.
Orthopedic · 73d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284
Globus Medical, Inc.
Orthopedic · 46d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 18, 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517
Spinal Concepts, Inc.
Orthopedic · 103d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Feb 12, 2004
TITANIUM MESH SYSTEM
K032371
Encore Medical, L.P.
Orthopedic · 195d
Cleared Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Dec 08, 2003
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
K032812
Orthovita, Inc.
Orthopedic · 90d