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
457–480 of 493
Cleared Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
K022622
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 155d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862
Synthes (Usa)
Orthopedic · 29d
Cleared Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
K013072
Synthes
Orthopedic · 439d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531
Biomet, Inc.
Orthopedic · 477d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared May 23, 2002
APATIGHT HA-BONE GRAFT SUBSTITUTE
K013960
Cerabio, LLC
Orthopedic · 171d
Cleared May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
K011726
Millenium Biologix, Inc.
Orthopedic · 346d
Cleared May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
K013966
Cerabio, LLC
Orthopedic · 164d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156
Curasan AG
Orthopedic · 89d
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053
Depuyacromed
Orthopedic · 88d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897
Synthes (Usa)
Orthopedic · 185d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048
DePuy Orthopaedics, Inc.
Orthopedic · 221d
Cleared Oct 26, 2001
OSTEOSET BVF KIT
K010532
Wrightmedicaltechnologyinc
Orthopedic · 245d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
K000122
Neucoll, Inc.
Orthopedic · 611d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386
Ebi, L.P.
Orthopedic · 88d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
K004003
Interpore Cross Intl.
Orthopedic · 206d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954
Biocomposites, Ltd.
Orthopedic · 203d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557
Smith & Nephew, Inc.
Orthopedic · 88d