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
145–168 of 492
Cleared Jun 23, 2017
ReBOSSIS85
K170620
Orthorebirth Co., Ltd.
Orthopedic · 114d
Cleared May 24, 2017
FIBERGRAFT BG Putty Bone Graft Substitute
K170306
Prosidyan, Inc.
Orthopedic · 113d
Cleared May 02, 2017
Vitoss Bioactive (BA) Injectable
K163621
Orthovita, Inc.
Orthopedic · 131d
Cleared Apr 18, 2017
NovoGro
K162087
Osteonovus, Inc.
Orthopedic · 264d
Cleared Feb 24, 2017
MagnetOs
K161859
Xpand Biotechnology BV
Orthopedic · 233d
Cleared Feb 16, 2017
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
K161996
Amend Surgical, Inc.
Orthopedic · 212d
Cleared Feb 13, 2017
MCS Bone Graft
K162860
Bioventus, LLC
Orthopedic · 124d
Cleared Jan 18, 2017
NovaBone IRM
K163310
Novabone Products, LLC
Orthopedic · 56d
Cleared Dec 02, 2016
Cerasorb Ortho Foam
K160566
Curasan AG
Orthopedic · 277d
Cleared Nov 07, 2016
MCP Bone Putty
K160446
Biostructures, LLC
Orthopedic · 264d
Cleared Oct 26, 2016
NanoBone SBX Putty
K161351
Artoss GmbH
Orthopedic · 163d
Cleared Oct 06, 2016
HydroSet XT
K161447
Orthovita, Inc.
Orthopedic · 134d
Cleared Apr 21, 2016
MaxiGen
K152077
Hans Biomed Corp.
Orthopedic · 269d
Cleared Mar 11, 2016
BellaFuse
K151271
Hans Biomed Corp.
Orthopedic · 303d
Cleared Feb 12, 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608
Orthovita, Inc.
Orthopedic · 57d
Cleared Jan 12, 2016
Bio2 CLM BG Bioactive Scaffold
K152589
Bio2 Technologies, Inc.
Orthopedic · 124d
Cleared Nov 10, 2015
FIBERGRAFT BG Morsels
K151154
Prosidyan, Inc.
Orthopedic · 194d
Cleared Oct 08, 2015
AttraX Putty
K151584
Progentix Orthobiology BV
Orthopedic · 119d
Cleared Sep 04, 2015
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
K150064
Orthogem, Ltd.
Orthopedic · 234d
Cleared Aug 26, 2015
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
K152071
Novabone Products, LLC
Orthopedic · 30d
Cleared Aug 21, 2015
GranOSTM - beta tricalcium phosphate synthetic bone granules
K143692
Tcm Associates, Ltd.
Orthopedic · 240d
Cleared Aug 18, 2015
OsteoSelect PLUS Demineralized Bone Matrix Putty
K150621
Bacterin International, Inc.
Orthopedic · 160d
Cleared Aug 14, 2015
MASTERGRAFT Contain
K151172
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Jul 09, 2015
BONGOLD BONE GRAFT MATERIAL
K141725
Beijing Allgens Medical Science & Technology Co, L
Orthopedic · 378d