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 Kuros Biosciences B.V.

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
241–264 of 492
Cleared Feb 18, 2010
CARRIGEN
K093447
Etex Corp.
Orthopedic · 105d
Cleared Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302
Integra LifeSciences Corporation
Orthopedic · 214d
Cleared Nov 17, 2009
PIONEER SURGICAL NANOSS BVF-E
K091031
Pioneer Surgical Technology
Orthopedic · 221d
Cleared Nov 02, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091607
Etex Corp.
Orthopedic · 152d
Cleared Sep 28, 2009
KAINOS+
K090387
Signus Medizintechnik GmbH
Orthopedic · 223d
Cleared Sep 28, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091218
Musculoskeletal Transplant Foundation
Orthopedic · 154d
Cleared Sep 18, 2009
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
K090855
Etex Corp.
Orthopedic · 172d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270
Wrightmedicaltechnologyinc
Orthopedic · 294d
Cleared Jun 12, 2009
E-MATRIX GRAFT BONE EXTENDER
K083449
Pioneer Surgical Technology
Orthopedic · 203d
Cleared Jun 02, 2009
MASTERGRAFT STRIP
K082166
Medtronic Sofamor Danek
Orthopedic · 306d
Cleared Apr 15, 2009
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
K090731
Novabone Products, LLC
Orthopedic · 27d
Cleared Apr 02, 2009
INTERGRO DBM
K082793
Biomet Spine
Orthopedic · 191d
Cleared Mar 24, 2009
EQUIVABONE
K090310
Etex Corp.
Orthopedic · 46d
Cleared Feb 20, 2009
GAMMA-BSM, BETA-BSM
K090242
Etex Corp.
Orthopedic · 18d
Cleared Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232
Globus Medical, Inc.
Orthopedic · 51d
Cleared Dec 09, 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K082672
Novabone Products, LLC
Orthopedic · 85d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Nov 14, 2008
GENEX
K082381
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Nov 06, 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K083033
Orthovita, Inc.
Orthopedic · 27d
Cleared Oct 16, 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
K082615
Osteotech, Inc.
Orthopedic · 37d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 07, 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442
Globus Medical, Inc.
Orthopedic · 43d
Cleared Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
K081758
Depuy Spine, Inc.
Orthopedic · 75d