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
361–384 of 493
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 31, 2006
THERIGRAFT TCP PUTTY BONE VOID FILLER
K053228
Therics, LLC
Orthopedic · 74d
Cleared Jan 25, 2006
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812
Collagen Matrix, Inc.
Orthopedic · 113d
Cleared Jan 20, 2006
MBCP
K051774
Biomatlante
Orthopedic · 203d
Cleared Dec 30, 2005
STRYKER INJECTABLE CEMENT
K051603
Stryker Leibinger Micro Implants
Orthopedic · 198d
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 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