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
289–312 of 493
Cleared Sep 11, 2008
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
K082073
Apatech , Ltd.
Orthopedic · 50d
Cleared Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
K081758
Depuy Spine, Inc.
Orthopedic · 75d
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 20, 2008
CERAMENT BONE VOID FILLER, MODEL A0210
K073316
Bonesupport AB
Orthopedic · 207d
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 May 02, 2008
OSFERION
K080065
Olympus Terumo Biomaterials Corporation
Orthopedic · 113d
Cleared Apr 21, 2008
PLEXUR-P
K080511
Osteotech, Inc.
Orthopedic · 56d
Cleared Apr 16, 2008
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
K080736
Apatech , Ltd.
Orthopedic · 30d
Cleared Apr 15, 2008
COMPORUS
K062691
Takiron Co., Ltd.
Orthopedic · 582d
Cleared Apr 04, 2008
WELLGRAFT PE II
K072170
Gwowei Technology Co., Ltd.
Orthopedic · 242d
Cleared Apr 04, 2008
WELLGRAFT PE I
K072444
Gwowei Technology Co., Ltd.
Orthopedic · 242d
Cleared Mar 11, 2008
GRAFTYS BCP
K073064
Graftys
Orthopedic · 133d
Cleared Mar 10, 2008
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
K063157
Merries International, Inc.
Orthopedic · 510d
Cleared Mar 03, 2008
PLEXUR M
K073405
Osteotech, Inc.
Orthopedic · 90d
Cleared Feb 01, 2008
BONALIVE GRANULES
K071199
Vivoxid , Ltd.
Orthopedic · 277d
Cleared Jan 25, 2008
BIOSET XCH
K072238
Regeneration Technologies, Inc.
Orthopedic · 165d
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