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
313–336 of 493
Cleared Nov 09, 2007
MASTERGRAFT PUTTY
K071813
Medtronic Sofamor Danek
Orthopedic · 130d
Cleared Oct 29, 2007
APACERAM BONE GRAFT SUBSTITUTE
K071912
Pentax Corp.
Orthopedic · 110d
Cleared Oct 24, 2007
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
K072327
Regeneration Technologies, Inc.
Orthopedic · 65d
Cleared Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
K071046
Synthes (Usa)
Orthopedic · 193d
Cleared Oct 23, 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636
Etex Corp.
Orthopedic · 35d
Cleared Oct 15, 2007
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K070751
Isotis Orthobiologics, Inc.
Orthopedic · 210d
Cleared Oct 15, 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Oct 11, 2007
INION BIORESTORE
K070998
Inion OY
Orthopedic · 185d
Cleared Sep 26, 2007
OSSIFUSE BONE SUBSTITUTE MATERIAL
K072355
Etex Corp.
Orthopedic · 35d
Cleared Sep 21, 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384
Kensey Nash Corp.
Orthopedic · 28d
Cleared Sep 18, 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184
Orthovita, Inc.
Orthopedic · 43d
Cleared Sep 17, 2007
BONEMEDIK, AND BONEMEDIK-S
K070897
Meta Biomed Co., Ltd.
Orthopedic · 168d
Cleared Sep 17, 2007
INQU
K071428
Isto Technologies, Inc.
Orthopedic · 117d
Cleared Sep 11, 2007
TRIBONE 80
K071121
Biomatlante
Orthopedic · 144d
Cleared Aug 15, 2007
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
K061880
Isotis NV
Orthopedic · 408d
Cleared Jul 30, 2007
MBCP+
K063527
Biomatlante
Orthopedic · 250d
Cleared Jul 13, 2007
TRIPORE, MODELS HA, BP90, BP15
K070132
Orthogem Limited
Orthopedic · 178d
Cleared Jul 10, 2007
ATLANTIK
K070794
Medical Biomat
Orthopedic · 110d
Cleared Jul 03, 2007
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
K071155
Science For Biomaterials
Orthopedic · 69d
Cleared Jun 28, 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630
Etex Corp.
Orthopedic · 296d
Cleared Jun 01, 2007
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
K070864
Biomet Osteobiologics
Orthopedic · 65d
Cleared Jun 01, 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237
Kensey Nash Corp.
Orthopedic · 29d
Cleared May 31, 2007
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
K071206
Apatech , Ltd.
Orthopedic · 30d
Cleared May 09, 2007
PRO-DENSE BONE VOID FILLER
K070437
Wrightmedicaltechnologyinc
Orthopedic · 83d