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, Kuros Biosciences B.V and Synthes (Usa).

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
73–96 of 492
Cleared Feb 04, 2022
Genex Bone Graft Substitute
K212721
Biocomposites, Ltd.
Orthopedic · 161d
Cleared Jan 21, 2022
Osteorevive
K212991
Bone Solutions, Inc.
Orthopedic · 123d
Cleared Jan 10, 2022
MagnetOs granules
K213111
Kuros Biosciences B.V
Orthopedic · 108d
Cleared Jan 05, 2022
PRO-DENSE LoVisc Bone Graft Substitute
K213342
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 08, 2021
ABCcolla Bone Matrix
K212156
Acro Biomedical Co., Ltd.
Orthopedic · 88d
Cleared Oct 04, 2021
Dry DBM- A Putty
K212135
Seaspine Corporation
Orthopedic · 88d
Cleared Sep 22, 2021
DB-EZ Bone Void Filler
K212353
Dimensional Bioceramics, LLC
Orthopedic · 55d
Cleared Sep 02, 2021
MagnetOs Easypack Putty
K211201
Kuros Biosciences B.V
Orthopedic · 133d
Cleared Aug 31, 2021
Tactoset Injectable Bone Substitute
K212083
Anika Therapeutics, Inc.
Orthopedic · 60d
Cleared May 04, 2021
CaP Spheres Pellet Pack
K203218
Zimmer Biomet Spine, Inc.
Orthopedic · 183d
Cleared Apr 21, 2021
si-Mochi
K202639
Biostone, Ltd.
Orthopedic · 222d
Cleared Mar 15, 2021
DB-Composite
K210193
Dimensional Bioceramics, LLC
Orthopedic · 49d
Cleared Dec 28, 2020
Uni-FuZe-P Bone Putty
K201781
Zavation Medical Products, LLC
Orthopedic · 181d
Cleared Oct 21, 2020
PRO-DENSE LoVisc Bone Graft Substitute
K200507
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Oct 16, 2020
Cerament Bone Void Filler
K201535
Bonesupport AB
Orthopedic · 130d
Cleared Aug 14, 2020
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
K200064
SurGenTec, LLC
Orthopedic · 214d
Cleared Aug 04, 2020
CureOs TCP
K191670
Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
Orthopedic · 410d
Cleared Jun 30, 2020
Altapore MIS
K201464
Baxter Healthcare Corporation
Orthopedic · 28d
Cleared Jun 18, 2020
SIGNAFUSE Bioactive Bone Graft
K193513
Bioventus
Orthopedic · 182d
Cleared Jun 09, 2020
Osteo3 ZP Putty
K193075
Sirakoss , Ltd.
Orthopedic · 218d
Cleared May 11, 2020
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
K200290
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared May 08, 2020
ALTAPORE SHAPE
K200640
Baxter Healthcare Corporation
Orthopedic · 58d
Cleared Apr 22, 2020
DB-Orthopedics
K200752
Dimensional Bioceramics, LLC
Orthopedic · 30d
Cleared Mar 30, 2020
Agilon Strip
K193487
Biogennix, LLC
Orthopedic · 104d