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
Dec 27, 2001
SPINAL MESH SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
233d
Cleared
Nov 07, 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
Interpore Cross Intl.
Orthopedic
218d
Cleared
Nov 07, 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
Depuyacromed
Orthopedic
26d
Cleared
Oct 24, 2001
LIFT VB SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
210d
Cleared
Aug 03, 2001
GEO STRUCTURE
Interpore Cross Intl.
Orthopedic
161d
Cleared
Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
United States Surgical, A Division of Tyco Healthc
Orthopedic
229d
Cleared
May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
Depuyacromed
Orthopedic
221d
Cleared
Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
Synthes (Usa)
Orthopedic
186d
Cleared
Jul 26, 2000
STACKABLE CAGE SYSTEM
Depuyacromed
Orthopedic
90d