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 Kuros Biosciences B.V.

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
193–216 of 492
Cleared Apr 18, 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 08, 2014
ULTRAFUSE
K130531
Baxter Healthcare Corp
Orthopedic · 403d
Cleared Mar 24, 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Mar 14, 2014
BG MORSELS
K132805
Prosidyan, Inc.
Orthopedic · 189d
Cleared Feb 07, 2014
NB3D BONE VOID FILLER
K132050
Pioneer Surgical Technology, Inc.
Orthopedic · 220d
Cleared Jan 10, 2014
BIOACTIVE BONE GRAFT PUTTY
K132071
Biostructures, LLC
Orthopedic · 191d
Cleared Dec 24, 2013
SIGNIFY BIOACTIVE
K130977
Globus Medical, Inc.
Orthopedic · 259d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Aug 15, 2013
KINEX BIOACTIVE
K130392
Globus Medical, Inc.
Orthopedic · 181d
Cleared Aug 12, 2013
VIVORTE BVF LITE
K131133
Vivorte, Inc.
Orthopedic · 111d
Cleared Jul 15, 2013
NEOTIS
K130953
Sbm Sciences For Bio Materials
Orthopedic · 101d
Cleared Apr 19, 2013
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
K122868
Synergy Biomedical, LLC
Orthopedic · 213d
Cleared Apr 19, 2013
MASTERGRAFT STRIP
K130335
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 67d
Cleared Mar 25, 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871
Wrightmedicaltechnologyinc
Orthopedic · 451d
Cleared Mar 21, 2013
BETA-TCP GRANULES
K120354
Skeletal Kinetics, LLC
Orthopedic · 409d
Cleared Feb 05, 2013
A-GRIX TE RESORABLE BONE VOID FILLER
K121453
Ag Digital Technology Corp.
Orthopedic · 265d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Jan 11, 2013
MTF NEW BONE VOID FILLER
K121313
Musculoskeletal Transplant Foundation
Orthopedic · 254d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989
Exactech, Inc.
Orthopedic · 144d
Cleared Sep 18, 2012
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949
Wiltrom Corporation Limited
Orthopedic · 533d
Cleared May 04, 2012
KENSEY NASH BONE VOID FILLER XC
K120141
Kensey Nash Cororation
Orthopedic · 107d
Cleared Apr 06, 2012
NANOFUSE DBM
K120279
Nanotherapeutics
Orthopedic · 67d
Cleared Mar 23, 2012
APACERAM BONE GRAFT SUBSTITUTE
K120602
Hoya Corporation
Orthopedic · 24d
Cleared Mar 15, 2012
B-GENIN, R-GENIN
K113791
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 84d