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
409–432 of 493
Cleared Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616
Orthos (Uk) Limited
Orthopedic · 71d
Cleared Aug 19, 2004
CEMENTEK
K041493
Teknimed, S.A.
Orthopedic · 76d
Cleared Aug 19, 2004
TRI-OSTETIC
K041889
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 38d
Cleared Aug 16, 2004
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
K033707
Osteobiologics, Inc.
Orthopedic · 264d
Cleared Aug 04, 2004
PORE-SI BONE GRAFT SUBSTITUTE
K040082
Apatech , Ltd.
Orthopedic · 202d
Cleared Aug 02, 2004
ALLOMATRIX PUTTY
K041168
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 23, 2004
NORIAN SRS FAST SET PUTTY
K041842
Synthes (Usa)
Orthopedic · 15d
Cleared Jul 14, 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
K040980
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 07, 2004
COPSIOS BONE VOID FILLER (BVF)
K033679
Centerpulse Spine-Tech, Inc.
Orthopedic · 226d
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 10, 2004
JAX-TCP
K033552
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared May 12, 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
K040381
Arthrex, Inc.
Orthopedic · 85d
Cleared May 07, 2004
APAPORE BONE GRAFT SUBSTITUTE
K033722
Apatech , Ltd.
Orthopedic · 163d
Cleared May 07, 2004
BIOFILL BONE VOID FILLER
K040454
Scient'X
Orthopedic · 74d
Cleared May 07, 2004
GENEX BONE GRAFT SUBSTITUTE
K040600
Biocomposites, Ltd.
Orthopedic · 60d
Cleared May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514
Ortho Tec, LLC
Orthopedic · 66d
Cleared May 03, 2004
CERAFORM BONE VOID FILLER
K040669
Teknimed, S.A.
Orthopedic · 49d
Cleared Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611
Biomet, Inc.
Orthopedic · 162d
Cleared Apr 02, 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828
Wrightmedicaltechnologyinc
Orthopedic · 585d
Cleared Mar 26, 2004
CERASORB M ORTHO
K040216
Curasan AG
Orthopedic · 56d
Cleared Mar 09, 2004
BONESAVE BONE VOID FILLER
K033258
Howmedica Osteonics
Orthopedic · 152d
Cleared Mar 09, 2004
THERILINK BONE VOID FILLER
K040134
Therics, Inc.
Orthopedic · 48d
Cleared Mar 05, 2004
ALLOMATRIX MODEL# 86
K020895
Wrightmedicaltechnologyinc
Orthopedic · 717d
Cleared Mar 05, 2004
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
K040405
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 17d