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
241–264 of 493
Cleared Sep 01, 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860
Novabone Products, LLC
Orthopedic · 61d
Cleared Aug 19, 2010
BONEOPTIMIZER
K100841
Curasan AG
Orthopedic · 147d
Cleared Jul 29, 2010
BIOGENNIX RPC
K093342
Biogennix, LLC
Orthopedic · 276d
Cleared Jul 20, 2010
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
K100986
Skeletal Kinetics, LLC
Orthopedic · 102d
Cleared Jul 01, 2010
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557
Etex Corp.
Orthopedic · 27d
Cleared Jun 23, 2010
B-GENIN AND R-GENIN
K091912
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 363d
Cleared May 28, 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608
Collagen Matrix, Inc.
Orthopedic · 276d
Cleared Apr 22, 2010
GRAFTY QUICKSET
K093343
Graftys
Orthopedic · 178d
Cleared Apr 22, 2010
NANOSS BONE VOID FILLER
K100361
Pioneer Surgical Technology
Orthopedic · 69d
Cleared Mar 24, 2010
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
K092046
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 261d
Cleared Mar 02, 2010
A-GRIX RESORBABLE BONE VOID FILLER
K091688
Ag Digital Technology Corp.
Orthopedic · 265d
Cleared Feb 18, 2010
CARRIGEN
K093447
Etex Corp.
Orthopedic · 105d
Cleared Jan 08, 2010
ORTHOSS
K090401
Ed. Geistlich Soehne AG Fur Chemische Industrie
Orthopedic · 325d
Cleared Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302
Integra LifeSciences Corporation
Orthopedic · 214d
Cleared Dec 01, 2009
DUOWEDGE SYNTHETIC BONE SUBSTITUTE
K073214
Kasios
Orthopedic · 748d
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 Oct 23, 2009
CURIOS
K090641
Progentix Orthobiology BV
Orthopedic · 227d
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 Sep 11, 2009
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K091321
Bacterin International, Inc.
Orthopedic · 129d
Cleared Sep 04, 2009
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
K090871
Bonesupport AB
Orthopedic · 158d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270
Wrightmedicaltechnologyinc
Orthopedic · 294d