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
121–144 of 492
Cleared Aug 31, 2018
ALTAPORE
K181225
Baxter Healthcare Corporation
Orthopedic · 115d
Cleared Aug 31, 2018
CarriGen PF
K182107
Etex Corporation
Orthopedic · 28d
Cleared Aug 17, 2018
Actifuse Flow
K181306
Baxter Healthcare Corporation
Orthopedic · 92d
Cleared Aug 06, 2018
EP Granules™ BVF
K180853
Elute, Inc.
Orthopedic · 126d
Cleared Jul 20, 2018
JGH1 Core Deccompression Procedure Kit
K181585
AgNovos Healthcare USA, LLC
Orthopedic · 35d
Cleared Jul 19, 2018
JGH1 Bone Graft Substitute
K181342
AgNovos Healthcare USA, LLC
Orthopedic · 59d
Cleared May 09, 2018
DSM Biomedical Calcium Phosphate Cement with Microspheres
K173572
Kensey Nash Corporation Dba Dsm Biomedical
Orthopedic · 170d
Cleared Apr 11, 2018
Rafugen DBM
K180121
Cellumed Co., Ltd.
Orthopedic · 85d
Cleared Apr 06, 2018
NovoGro
K173525
Osteonovus, Inc.
Orthopedic · 143d
Cleared Apr 06, 2018
FIBERGRAFT BG Matrix Bone Graft Substitute
K180080
Prosidyan, Inc.
Orthopedic · 86d
Cleared Apr 03, 2018
DSM Biomedical Calcium Phosphate Cement
K173362
Kensey Nash Corporation Dba Dsm Biomedical
Orthopedic · 159d
Cleared Feb 22, 2018
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
K171568
Hans Biomed Corporation
Orthopedic · 268d
Cleared Feb 02, 2018
Bicera Resorbable Bone Substitute
K172237
Wiltrom Corporation Limited
Orthopedic · 192d
Cleared Feb 01, 2018
ABCcolla Bone Graft
K171629
Acro Biomedical Co., Ltd.
Orthopedic · 244d
Cleared Jan 19, 2018
BioSphere MIS Putty (BioSphere MIS)
K173301
Synergy Biomedical, LLC
Orthopedic · 94d
Cleared Nov 24, 2017
NuVasive AttraX Scaffold
K172497
Nu Vasive, Incorporated
Orthopedic · 98d
Cleared Aug 04, 2014
AS20 COMPOSITE GRAFT
K141746
Wrightmedicaltechnologyinc
Orthopedic · 35d
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 25, 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871
Wrightmedicaltechnologyinc
Orthopedic · 451d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270
Wrightmedicaltechnologyinc
Orthopedic · 294d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
K071046
Synthes (Usa)
Orthopedic · 193d