FDA.reportPublic FDA data

Opus Mg Set BVF

Primary DI
B4477120050
Brand
Opus Mg Set BVF
Company
BONE SOLUTIONS, INC.
Model
5cc
Catalog number
712005
Device description
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
Published
2021-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4477120050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit89 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8178098850customerservice@bonesolutions.net

Regulatory Flags#

DUNS number
003506272
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080243145T-Han Delivery System4.2 x 180mmRM44-0532026-02-13
00850080243152T-Han Delivery System4.2 x 350mmRM44-0632026-02-13
00850080243169T-Han Delivery System4.2 x 450mmRM44-0732026-02-13
B4474410000INJ0Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2024-05-20
B4474405000REV0Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2022-02-02
B4474410000REV0Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2022-02-02
B4474415000REV0Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2022-02-02
B4474405000INJ0Mg OSTEOINJECT® bone graft substitute 5cc44-050-00-INJ2022-01-11
B4477120010Mixing and Delivery SystemBeat Mat Pak7120012021-09-27
B447RM4405010Mixing and Delivery SystemBeat Mat PakRM44-0502020-07-30
B447RM4405110Mixing and Delivery SystemMechanical Advantage PakRM 44-0512020-07-30
B4474405000STR0Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-STR2020-02-19
B4474410000BSI0Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-BSI2020-02-19
B4474410000STR0Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-STR2020-02-19
B4474415000BSI0Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-BSI2020-02-19
B4474415000STR0Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-STR2020-02-19
B4474405000BSI0Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-BSI2017-08-04
B4477120000Opus Mg Set - Mixing and Delivery SystemAUX7120002021-09-27
B4477120100Opus Mg Set BVF10cc7120102021-09-27
B4477120150Opus Mg Set BVF15cc7120152021-09-27

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