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
217–240 of 279
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037
Synthes (Usa)
Orthopedic · 452d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025
Implex Corp.
Orthopedic · 52d
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887
Ebi, L.P.
Orthopedic · 59d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152
Synthes (Usa)
Orthopedic · 89d
Cleared Mar 21, 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522
Depuyacromed
Orthopedic · 30d
Cleared Feb 21, 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
K020204
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378
Implex Corp.
Orthopedic · 354d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145
Interpore Cross Intl.
Orthopedic · 30d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Nov 07, 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
K010989
Interpore Cross Intl.
Orthopedic · 218d
Cleared Nov 07, 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382
Depuyacromed
Orthopedic · 26d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 16, 2001
VBR
K012254
Osteotech, Inc.
Orthopedic · 90d
Cleared Aug 03, 2001
GEO STRUCTURE
K010530
Interpore Cross Intl.
Orthopedic · 161d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709
United States Surgical, A Division of Tyco Healthc
Orthopedic · 229d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043
Depuyacromed
Orthopedic · 221d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275
Synthes (Usa)
Orthopedic · 186d
Cleared Jan 04, 2001
VERTEBRAL BODY REPLACEMENT
K003155
Osteotech, Inc.
Orthopedic · 86d
Cleared Jul 26, 2000
STACKABLE CAGE SYSTEM
K001340
Depuyacromed
Orthopedic · 90d
Cleared Jul 05, 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667
Ionics Medical Corp.
Orthopedic · 625d
Cleared Sep 03, 1999
STACKABLE CAGE SYSTEM
K990148
Depuy Motech Acromed
Orthopedic · 227d