MQV · Class II · 21 CFR 888.3045

FDA Product Code MQV: Filler, Bone Void, Calcium Compound

Under FDA product code MQV, calcium compound bone void fillers are cleared for use in orthopedic and spinal surgery.

These synthetic graft materials — including calcium phosphate, calcium sulfate, and hydroxyapatite formulations — are used to fill bone defects created by trauma, tumor resection, or surgical procedures. They resorb over time as new bone grows to replace them.

MQV devices are Class II medical devices, regulated under 21 CFR 888.3045 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Wrightmedicaltechnologyinc, Novabone Products, LLC and Orthovita, Inc..

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
289–312 of 492
Cleared Feb 13, 2007
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
K062200
Collagen Matrix, Inc.
Orthopedic · 196d
Cleared Jan 26, 2007
OSFERION
K061499
Olympus America, Inc.
Orthopedic · 240d
Cleared Jan 19, 2007
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124
Integra Lifesciences Corp.
Orthopedic · 98d
Cleared Dec 28, 2006
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
K053218
Musculoskeletal Transplant Foundation
Orthopedic · 406d
Cleared Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353
Integra LifeSciences Corporation
Orthopedic · 131d
Cleared Dec 15, 2006
BF+ (PH)
K061462
Ldr Spine USA
Orthopedic · 203d
Cleared Oct 13, 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495
Depuy Spine, Inc.
Orthopedic · 49d
Cleared Sep 22, 2006
ALLOGRAN-R
K061311
Biocomposites, Ltd.
Orthopedic · 135d
Cleared Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
K061939
Wrightmedicaltechnologyinc
Orthopedic · 8d
Cleared May 01, 2006
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
K060728
Novabone Products, LLC
Orthopedic · 45d
Cleared Apr 04, 2006
NOVABONE POROUS-BONE GRAFT SCAFFOLD
K060432
Novabone Products, LLC
Orthopedic · 42d
Cleared Mar 21, 2006
NORIAN SRS BONE VOID FILLER
K060408
Synthes (Usa)
Orthopedic · 33d
Cleared Mar 20, 2006
NORIAN SRS FAST SET PUTTY
K060406
Synthes (Usa)
Orthopedic · 32d
Cleared Mar 08, 2006
COLLOSS E BONE VOID FILLER
K051047
Ossacur AG
Orthopedic · 317d
Cleared Mar 06, 2006
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
K051617
Novabone Products, LLC
Orthopedic · 262d
Cleared Mar 06, 2006
ALLOMATRIX CUSTOM
K053319
Wrightmedicaltechnologyinc
Orthopedic · 96d
Cleared Mar 01, 2006
STRYKER INJECTABLE CEMENT
K060061
Stryker Corp.
Orthopedic · 51d
Cleared Feb 27, 2006
MIIG SR
K060011
Wrightmedicaltechnologyinc
Orthopedic · 55d
Cleared Jan 25, 2006
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812
Collagen Matrix, Inc.
Orthopedic · 113d
Cleared Jan 20, 2006
MBCP
K051774
Biomatlante
Orthopedic · 203d
Cleared Dec 30, 2005
STRYKER INJECTABLE CEMENT
K051603
Stryker Leibinger Micro Implants
Orthopedic · 198d
Cleared Dec 16, 2005
MASTERGRAFT PUTTY BONE VOID FILLER
K051386
Medtronic Vascular
Orthopedic · 203d
Cleared Nov 18, 2005
TRICOS T
K051722
Baxter Healthcare Corp
Orthopedic · 144d
Cleared Nov 07, 2005
IGNITE BONE VOID FILLER KIT
K052913
Wrightmedicaltechnologyinc
Orthopedic · 21d