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 Berkeley Advanced Biomaterials, Inc..
493
Total
493
Cleared
149d
Avg days
1996
Since
493 devices
Cleared
Apr 18, 2007
PRO OSTEON 500R
Ebi, L.P.
Orthopedic
166d
Cleared
Apr 16, 2007
INQU
Isto Technologies, Inc.
Orthopedic
160d
Cleared
Apr 12, 2007
OSTEOFIX BONE VOID FILLER
Calcitec, Inc.
Orthopedic
79d
Cleared
Feb 26, 2007
ORIGEN DBM WITH BIOACTIVE GLASS
Nanotherapeutics
Orthopedic
187d
Cleared
Feb 13, 2007
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
Collagen Matrix, Inc.
Orthopedic
196d
Cleared
Jan 26, 2007
OSFERION
Olympus America, Inc.
Orthopedic
240d
Cleared
Jan 19, 2007
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
Integra Lifesciences Corp.
Orthopedic
98d
Cleared
Dec 28, 2006
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
Musculoskeletal Transplant Foundation
Orthopedic
406d
Cleared
Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
Integra LifeSciences Corporation
Orthopedic
131d
Cleared
Dec 15, 2006
BF+ (PH)
Ldr Spine USA
Orthopedic
203d
Cleared
Oct 19, 2006
OSTEOPORE TCP
Spinecraft, Inc.
Orthopedic
55d
Cleared
Oct 13, 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
Depuy Spine, Inc.
Orthopedic
49d
Cleared
Sep 22, 2006
KENSEY NASH BONE VOID FILLER
Kensey Nash Corporation
Orthopedic
171d
Cleared
Sep 22, 2006
ALLOGRAN-R
Biocomposites, Ltd.
Orthopedic
135d
Cleared
Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
Wrightmedicaltechnologyinc
Orthopedic
8d
Cleared
Jul 06, 2006
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
Berkeley Advanced Biomaterials, Inc.
Orthopedic
232d
Cleared
Jul 03, 2006
OSTEO-LINK BONE VOID FILLER PELLETS
Promed Advance Technology Co., Ltd.
Orthopedic
101d
Cleared
May 24, 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
Science For Biomaterials
Orthopedic
41d
Cleared
May 01, 2006
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
Novabone Products, LLC
Orthopedic
45d
Cleared
Apr 04, 2006
NOVABONE POROUS-BONE GRAFT SCAFFOLD
Novabone Products, LLC
Orthopedic
42d
Cleared
Mar 21, 2006
NORIAN SRS BONE VOID FILLER
Synthes (Usa)
Orthopedic
33d
Cleared
Mar 20, 2006
NORIAN SRS FAST SET PUTTY
Synthes (Usa)
Orthopedic
32d
Cleared
Mar 08, 2006
COLLOSS E BONE VOID FILLER
Ossacur AG
Orthopedic
317d
Cleared
Mar 06, 2006
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
Novabone Products, LLC
Orthopedic
262d