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
265–288 of 492
Cleared Aug 25, 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558
Pioneer Surgical Technology
Orthopedic · 83d
Cleared Jul 22, 2008
PLEXUR M
K081227
Osteotech, Inc.
Orthopedic · 83d
Cleared Jul 09, 2008
GENEX PUTTY
K073341
Biocomposites, Ltd.
Orthopedic · 224d
Cleared Jun 17, 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439
Orthovita, Inc.
Orthopedic · 26d
Cleared May 06, 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009
Novabone Products, LLC
Orthopedic · 124d
Cleared Apr 21, 2008
PLEXUR-P
K080511
Osteotech, Inc.
Orthopedic · 56d
Cleared Mar 03, 2008
PLEXUR M
K073405
Osteotech, Inc.
Orthopedic · 90d
Cleared Jan 09, 2008
PROGENIX DMB PUTTY
K072265
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Dec 20, 2007
MICROFUSE BONE VOID FILLER
K071187
Globus Medical, Inc.
Orthopedic · 234d
Cleared Dec 17, 2007
CROSS.BONE
K071876
TriMed, Inc.
Orthopedic · 164d
Cleared Nov 19, 2007
CAP PLUS
K063050
Etex Corp.
Orthopedic · 411d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Nov 09, 2007
MASTERGRAFT PUTTY
K071813
Medtronic Sofamor Danek
Orthopedic · 130d
Cleared Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
K071046
Synthes (Usa)
Orthopedic · 193d
Cleared Oct 23, 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636
Etex Corp.
Orthopedic · 35d
Cleared Oct 15, 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Sep 26, 2007
OSSIFUSE BONE SUBSTITUTE MATERIAL
K072355
Etex Corp.
Orthopedic · 35d
Cleared Sep 21, 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384
Kensey Nash Corp.
Orthopedic · 28d
Cleared Sep 18, 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184
Orthovita, Inc.
Orthopedic · 43d
Cleared Sep 17, 2007
BONEMEDIK, AND BONEMEDIK-S
K070897
Meta Biomed Co., Ltd.
Orthopedic · 168d
Cleared Jun 28, 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630
Etex Corp.
Orthopedic · 296d
Cleared Jun 01, 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237
Kensey Nash Corp.
Orthopedic · 29d
Cleared May 09, 2007
PRO-DENSE BONE VOID FILLER
K070437
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Apr 18, 2007
PRO OSTEON 500R
K063346
Ebi, L.P.
Orthopedic · 166d