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 Berkeley Advanced Biomaterials, Inc..

493
Total
493
Cleared
149d
Avg days
1996
Since
493 devices
337–360 of 493
Cleared Apr 18, 2007
PRO OSTEON 500R
K063346
Ebi, L.P.
Orthopedic · 166d
Cleared Apr 16, 2007
INQU
K063359
Isto Technologies, Inc.
Orthopedic · 160d
Cleared Apr 12, 2007
OSTEOFIX BONE VOID FILLER
K070220
Calcitec, Inc.
Orthopedic · 79d
Cleared Feb 26, 2007
ORIGEN DBM WITH BIOACTIVE GLASS
K062459
Nanotherapeutics
Orthopedic · 187d
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 19, 2006
OSTEOPORE TCP
K062496
Spinecraft, Inc.
Orthopedic · 55d
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
KENSEY NASH BONE VOID FILLER
K060917
Kensey Nash Corporation
Orthopedic · 171d
Cleared Sep 22, 2006
ALLOGRAN-R
K061311
Biocomposites, Ltd.
Orthopedic · 135d
Cleared Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
K061939
Wrightmedicaltechnologyinc
Orthopedic · 8d
Cleared Jul 06, 2006
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
K053213
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 232d
Cleared Jul 03, 2006
OSTEO-LINK BONE VOID FILLER PELLETS
K060809
Promed Advance Technology Co., Ltd.
Orthopedic · 101d
Cleared May 24, 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
K061022
Science For Biomaterials
Orthopedic · 41d
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