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 Biocomposites, Ltd..

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
169–192 of 492
Cleared Mar 25, 2015
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
K143533
Prosidyan, Inc.
Orthopedic · 103d
Cleared Feb 23, 2015
SORRENTO BONE GRAFT SUBSTITUTE
K141429
Haider Biologics, LLC
Orthopedic · 269d
Cleared Feb 20, 2015
CARRICELL
K132868
Etex Corporation
Orthopedic · 525d
Cleared Feb 17, 2015
NUROS BONE GRAFT SUBSTITUTE
K140913
Oriental Resources Development Limited
Orthopedic · 313d
Cleared Jan 30, 2015
NANOBONE / GRANULATE
K141189
Artoss GmbH
Orthopedic · 267d
Cleared Jan 23, 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830
Biocomposites, Ltd.
Orthopedic · 200d
Cleared Jan 21, 2015
NANOFUSE DBM
K142104
Nanotherapeutics, Inc.
Orthopedic · 173d
Cleared Jan 16, 2015
MCS Bone Graft
K142276
Biostructures, LLC
Orthopedic · 154d
Cleared Jan 15, 2015
osteoSPAN Morpheus
K142828
Biogennix
Orthopedic · 107d
Cleared Jan 14, 2015
Vivorte Trabexus
K143549
Vivorte, Inc.
Orthopedic · 30d
Cleared Dec 18, 2014
Bio2 CLM BG Bioactive Scaffold
K142463
Bio2 Technologies, Inc.
Orthopedic · 107d
Cleared Oct 31, 2014
NOVABONE BIOACTIVE STRIP
K141207
Novabone Products, LLC
Orthopedic · 175d
Cleared Oct 29, 2014
REBOSSIS
K142090
Orthorebirth Co., Ltd.
Orthopedic · 89d
Cleared Oct 17, 2014
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
K141600
Pioneer Surgical Technology, Inc. (Rti Surgical, I
Orthopedic · 123d
Cleared Sep 05, 2014
MASTERGRAFT MATRIX EXT
K141824
Medtronic Sofamor Danek, Inc.
Orthopedic · 60d
Cleared Aug 26, 2014
CONFIRM BIOACTIVE
K133678
Globus Medical, Inc.
Orthopedic · 270d
Cleared Aug 22, 2014
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
K140946
Novabone Products, LLC
Orthopedic · 130d
Cleared Aug 13, 2014
FIBERGRAFT BG MORSELS
K141956
Prosidyan, Inc.
Orthopedic · 26d
Cleared Aug 04, 2014
SKAFFOLD NMX BONE VOID FILLER
K132211
Skeletal Kinetics, LLC
Orthopedic · 384d
Cleared Aug 04, 2014
AS20 COMPOSITE GRAFT
K141746
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Aug 01, 2014
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
K141841
Integra Lifescience Corportation
Orthopedic · 24d
Cleared Jul 16, 2014
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
K140844
Synergy Biomedical, Inc.
Orthopedic · 105d
Cleared May 21, 2014
SOLUM IV BONE VOID FILLER
K132470
Spinesmith Partners, Llp
Orthopedic · 287d
Cleared May 20, 2014
OSTEOSPAN MORPHEUS
K132377
Biogennix, LLC
Orthopedic · 293d