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
Jun 11, 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
Medos International SARL
General & Plastic Surgery
179d
Cleared
Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
Camber Spine Technologies
Orthopedic
50d
Cleared
Dec 21, 2017
Blustone Synergy Silica System
Blustone Synergy
Orthopedic
141d
Cleared
Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
Medtronic Sofamor Danek
Orthopedic
82d
Cleared
Nov 09, 2017
FORTIFY Corpectomy Spacers
Globus Medical, Inc.
Orthopedic
448d
Cleared
Oct 26, 2017
Omnia Medical VBR
Omnia Medical, LLC
Orthopedic
86d
Cleared
Sep 15, 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Choicespine
Orthopedic
100d
Cleared
Aug 31, 2017
CAPRI Corpectomy Cage System
K2m
Orthopedic
84d
Cleared
May 16, 2017
VerteFIT Corpectomy Cage System
Ldr Spine USA, Inc.
Orthopedic
288d
Cleared
Apr 13, 2017
CAPRI Corpectomy Cage System
K2m
Orthopedic
97d
Cleared
Mar 30, 2017
NuVasive(r) Monolith Corpectomy System
Nu Vasive, Incorporated
Orthopedic
62d
Cleared
Dec 22, 2015
Rectangular Corpectomy Cage
Amendia, Inc.
Orthopedic
116d
Cleared
Sep 04, 2015
NuVasive PEEK Corpectomy Railed System
Nu Vasive, Incorporated
Orthopedic
88d
Cleared
Sep 03, 2015
NuVasive PEEK Corpectomy System
Nu Vasive, Incorporated
Orthopedic
125d
Cleared
Jul 10, 2015
SpineFab Vertebral Body Replacement (VBR) System
Oxford Performance Materials
Orthopedic
352d
Cleared
Feb 20, 2015
NuVasive X-CORE(R) Expandable VBR System
Nuvasive, Inc.
Orthopedic
193d
Cleared
Feb 19, 2015
StaXx(R) XD System
Spine Wave, Inc.
Orthopedic
126d
Cleared
Jan 26, 2015
VERTA Corpectomy Cage
Camber Spine
Orthopedic
49d
Cleared
Jan 23, 2015
STGC-LORDOTIC
Cardinal Spine, LLC
Orthopedic
182d
Cleared
Nov 06, 2014
CAPRI
K2m, Inc.
Orthopedic
104d
Cleared
Oct 29, 2014
AIS MODULIFT VBR SYSTEM
Aesculap Implant System, Inc.
Orthopedic
85d
Cleared
Aug 07, 2014
LATERAL VBR SYSTEM
Nu Vasive, Incorporated
Orthopedic
155d
Cleared
Apr 17, 2014
AIS MODULIFT VBR SYSTEM
Aesculap Implant System, Inc.
Orthopedic
125d
Cleared
Jan 14, 2014
TASMIN R
Signus Medizintechnik GmbH
Orthopedic
403d