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
217–240 of 493
Cleared Mar 15, 2012
B-GENIN, R-GENIN
K113791
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 84d
Cleared Feb 14, 2012
POLYFUSE - NEUROBONE
K111018
Atpac Medical, LLC
Orthopedic · 308d
Cleared Feb 07, 2012
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383
Skeletal Kinetics, LLC
Orthopedic · 173d
Cleared Jan 24, 2012
MTF NEW BONE VOILD FILLER
K113167
Musculoskeletal Transplant Foundation
Orthopedic · 89d
Cleared Dec 13, 2011
INTERFACE BONE VOID FILLER
K112857
Biostructures, LLC
Orthopedic · 74d
Cleared Nov 22, 2011
NB3D BONE VOID FILLER
K111944
Pioneer Surgical Technology, Inc.
Orthopedic · 137d
Cleared Oct 14, 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773
Novabone Products, LLC
Orthopedic · 21d
Cleared Oct 13, 2011
MTF NEW BONE VOID FILLER
K110003
Musculoskeletal Transplant Foundation
Orthopedic · 283d
Cleared Sep 26, 2011
INQU PASTE MIX
K111838
Isto Technologies, Inc.
Orthopedic · 89d
Cleared Aug 29, 2011
INQU PASTE MIX PLUS
K103799
Isto Technologies, Inc.
Orthopedic · 244d
Cleared Jul 05, 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925
Novabone Products, LLC
Orthopedic · 95d
Cleared May 03, 2011
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
K110976
Nanotherapeutics, Inc.
Orthopedic · 26d
Cleared Apr 29, 2011
FORTROSS BONE VOID FILLER
K110561
Pioneer Surgical Technology
Orthopedic · 60d
Cleared Apr 21, 2011
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
K110787
Orthogem Limited
Orthopedic · 31d
Cleared Apr 14, 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K110368
Novabone Products, LLC
Orthopedic · 65d
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103784
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103795
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Feb 07, 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
K103173
Orthovita, Inc.
Orthopedic · 102d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722
Synthes USA Products, LLC
Orthopedic · 128d
Cleared Jan 10, 2011
ALLOFUSE PLUS
K103036
Allosource, Inc.
Orthopedic · 89d
Cleared Dec 27, 2010
OSTEOPHIL BETA-TCP
K102937
Cytophil, Inc.
Orthopedic · 84d
Cleared Dec 22, 2010
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392
Globus Medical, Inc.
Orthopedic · 121d
Cleared Nov 09, 2010
INTERFACE
K092541
Biostructures
Orthopedic · 447d
Cleared Oct 27, 2010
FM-02 BONE GRAFT SUBSTITUTE
K102545
Orthovita, Inc.
Orthopedic · 54d