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
169–192 of 492
Cleared Jan 09, 2008
PROGENIX DMB PUTTY
K072265
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Dec 20, 2007
MICROFUSE BONE VOID FILLER
K071187
Globus Medical, Inc.
Orthopedic · 234d
Cleared Dec 17, 2007
CROSS.BONE
K071876
TriMed, Inc.
Orthopedic · 164d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Nov 09, 2007
MASTERGRAFT PUTTY
K071813
Medtronic Sofamor Danek
Orthopedic · 130d
Cleared Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
K071046
Synthes (Usa)
Orthopedic · 193d
Cleared Oct 15, 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 09, 2007
PRO-DENSE BONE VOID FILLER
K070437
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Apr 18, 2007
PRO OSTEON 500R
K063346
Ebi, L.P.
Orthopedic · 166d
Cleared Feb 13, 2007
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
K062200
Collagen Matrix, Inc.
Orthopedic · 196d
Cleared Jan 26, 2007
OSFERION
K061499
Olympus America, Inc.
Orthopedic · 240d
Cleared Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353
Integra LifeSciences Corporation
Orthopedic · 131d
Cleared Oct 13, 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495
Depuy Spine, Inc.
Orthopedic · 49d
Cleared Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
K061939
Wrightmedicaltechnologyinc
Orthopedic · 8d
Cleared Mar 21, 2006
NORIAN SRS BONE VOID FILLER
K060408
Synthes (Usa)
Orthopedic · 33d
Cleared Mar 20, 2006
NORIAN SRS FAST SET PUTTY
K060406
Synthes (Usa)
Orthopedic · 32d
Cleared Mar 06, 2006
ALLOMATRIX CUSTOM
K053319
Wrightmedicaltechnologyinc
Orthopedic · 96d
Cleared Mar 01, 2006
STRYKER INJECTABLE CEMENT
K060061
Stryker Corp.
Orthopedic · 51d
Cleared Feb 27, 2006
MIIG SR
K060011
Wrightmedicaltechnologyinc
Orthopedic · 55d
Cleared Jan 25, 2006
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812
Collagen Matrix, Inc.
Orthopedic · 113d
Cleared Dec 16, 2005
MASTERGRAFT PUTTY BONE VOID FILLER
K051386
Medtronic Vascular
Orthopedic · 203d
Cleared Nov 18, 2005
TRICOS T
K051722
Baxter Healthcare Corp
Orthopedic · 144d
Cleared Nov 07, 2005
IGNITE BONE VOID FILLER KIT
K052913
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Feb 18, 2005
INTERGRO DBM
K031399
Interpore Cross Intl.
Orthopedic · 655d