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 Orthovita, Inc..

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
313–336 of 492
Cleared Nov 03, 2005
GENEROS 80, GENEROS 60
K051914
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 112d
Cleared Nov 03, 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494
Novabone Products, LLC
Orthopedic · 52d
Cleared Sep 29, 2005
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
K051698
Merries International, Inc.
Orthopedic · 97d
Cleared Sep 28, 2005
CERAMENT BONE VOID FILLER
K051951
Bonesupport AB
Orthopedic · 72d
Cleared Sep 07, 2005
CONNEXUS, .5CC, MODEL 023000-005
K052098
Isotis Orthobiologics, Inc.
Orthopedic · 35d
Cleared Sep 06, 2005
OSTEOMIMETIC SYNTHETIC BONE MATRIX
K051775
Biomimetic Pharmaceuticals, Inc.
Orthopedic · 67d
Cleared Aug 15, 2005
STERLING CANCELLOUS CHIPS
K051615
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Aug 01, 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406
Nexa Orthopedics, Inc.
Orthopedic · 62d
Cleared Jul 28, 2005
AFT
K042125
Musculoskeletal Transplant Foundation
Orthopedic · 356d
Cleared Jul 19, 2005
MARROW PLUS (M+)
K051695
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 26d
Cleared Jul 07, 2005
CONNEXUS
K050690
Isotis Orthobiologics, Inc.
Orthopedic · 112d
Cleared Jun 23, 2005
SYNTHACER
K041177
Medartis Medizinprodukte Und Forschung AG
Orthopedic · 414d
Cleared Jun 03, 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123
Skeletal Kinetics, LLC
Orthopedic · 31d
Cleared May 27, 2005
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
K050789
R and D Medical, LLC
Orthopedic · 60d
Cleared May 03, 2005
MODIFICATION TO MBCP
K043005
Biomatlante
Orthopedic · 183d
Cleared Apr 21, 2005
CAMCERAM TCP
K050357
Cam Implants B.V.
Orthopedic · 66d
Cleared Apr 11, 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490
Medicrea
Orthopedic · 45d
Cleared Apr 11, 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
K050666
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 28d
Cleared Mar 29, 2005
OSSAPLAST ORTHO
K050416
Ossacur AG
Orthopedic · 39d
Cleared Mar 17, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262
Musculoskeletal Transplant Foundation
Orthopedic · 407d
Cleared Feb 18, 2005
INTERGRO DBM
K031399
Interpore Cross Intl.
Orthopedic · 655d
Cleared Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308
Depuy Spine, Inc.
Orthopedic · 77d
Cleared Feb 16, 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
K043421
Regeneration Technologies, Inc.
Orthopedic · 65d
Cleared Feb 10, 2005
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
K043420
Regeneration Technologies, Inc.
Orthopedic · 59d