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
385–408 of 493
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 25, 2005
DYNAGRAFT II
K040419
Isotis Orthobiologics, Inc.
Orthopedic · 401d
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
Cleared Feb 03, 2005
NANOSS BONE VOID FILLER
K050025
Angstrom Medica, Inc.
Orthopedic · 28d
Cleared Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
K043514
Biocomposites, Ltd.
Orthopedic · 32d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045
Synthes (Usa)
Orthopedic · 64d
Cleared Jan 07, 2005
BF+
K043347
Ldr Spine USA
Orthopedic · 32d
Cleared Dec 27, 2004
CEMENTEK LV
K042911
Teknimed, S.A.
Orthopedic · 67d
Cleared Dec 17, 2004
POLYGRAFT BGS
K040047
Osteobiologics, Inc.
Orthopedic · 340d
Cleared Dec 14, 2004
BIOPLUS
K042636
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 78d
Cleared Nov 24, 2004
KASIOS TCP
K042340
Kasios Biomaterials
Orthopedic · 86d
Cleared Oct 21, 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
K042305
Ossacur AG
Orthopedic · 57d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089
Biomet Manufacturing, Inc.
Orthopedic · 127d
Cleared Aug 26, 2004
NAME BONE VOID FILLER
K041421
Stryker Biotech
Orthopedic · 90d
Cleared Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613
Novabone Products, LLC
Orthopedic · 71d