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
25–48 of 279
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
K173787
Medos International SARL
General & Plastic Surgery · 179d
Cleared Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800
Camber Spine Technologies
Orthopedic · 50d
Cleared Dec 21, 2017
Blustone Synergy Silica System
K172330
Blustone Synergy
Orthopedic · 141d
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Nov 09, 2017
FORTIFY Corpectomy Spacers
K162315
Globus Medical, Inc.
Orthopedic · 448d
Cleared Oct 26, 2017
Omnia Medical VBR
K172323
Omnia Medical, LLC
Orthopedic · 86d
Cleared Sep 15, 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686
Choicespine
Orthopedic · 100d
Cleared Aug 31, 2017
CAPRI Corpectomy Cage System
K171704
K2m
Orthopedic · 84d
Cleared May 16, 2017
VerteFIT Corpectomy Cage System
K162133
Ldr Spine USA, Inc.
Orthopedic · 288d
Cleared Apr 13, 2017
CAPRI Corpectomy Cage System
K170055
K2m
Orthopedic · 97d
Cleared Mar 30, 2017
NuVasive(r) Monolith Corpectomy System
K170271
Nu Vasive, Incorporated
Orthopedic · 62d
Cleared Dec 22, 2015
Rectangular Corpectomy Cage
K152460
Amendia, Inc.
Orthopedic · 116d
Cleared Sep 04, 2015
NuVasive PEEK Corpectomy Railed System
K151538
Nu Vasive, Incorporated
Orthopedic · 88d
Cleared Sep 03, 2015
NuVasive PEEK Corpectomy System
K151167
Nu Vasive, Incorporated
Orthopedic · 125d
Cleared Jul 10, 2015
SpineFab Vertebral Body Replacement (VBR) System
K142005
Oxford Performance Materials
Orthopedic · 352d
Cleared Feb 20, 2015
NuVasive X-CORE(R) Expandable VBR System
K142205
Nuvasive, Inc.
Orthopedic · 193d
Cleared Feb 19, 2015
StaXx(R) XD System
K142996
Spine Wave, Inc.
Orthopedic · 126d
Cleared Jan 26, 2015
VERTA Corpectomy Cage
K143490
Camber Spine
Orthopedic · 49d
Cleared Jan 23, 2015
STGC-LORDOTIC
K142030
Cardinal Spine, LLC
Orthopedic · 182d
Cleared Nov 06, 2014
CAPRI
K142016
K2m, Inc.
Orthopedic · 104d
Cleared Oct 29, 2014
AIS MODULIFT VBR SYSTEM
K142150
Aesculap Implant System, Inc.
Orthopedic · 85d
Cleared Aug 07, 2014
LATERAL VBR SYSTEM
K140563
Nu Vasive, Incorporated
Orthopedic · 155d
Cleared Apr 17, 2014
AIS MODULIFT VBR SYSTEM
K133802
Aesculap Implant System, Inc.
Orthopedic · 125d
Cleared Jan 14, 2014
TASMIN R
K123758
Signus Medizintechnik GmbH
Orthopedic · 403d