FDA.reportPublic FDA data

Mg OSTEOINJECT® bone graft substitute

Primary DI
B4474405000INJ0
Brand
Mg OSTEOINJECT® bone graft substitute
Company
BONE SOLUTIONS, INC.
Model
5cc
Catalog number
44-050-00-INJ
Device description
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
Published
2022-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4474405000INJ0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and 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. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Contacts#

Phone, Email table
PhoneEmail
8178098850customerservice@bonesolutions.net

Regulatory Flags#

DUNS number
003506272
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080243176OSTEOROD Delivery SystemOSTEORODRM44-0702026-10-12
00850080243022Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-STR2026-06-18
00850080243039Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-STR2026-06-18
00850080243046Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-STR2026-06-18
00850080243053Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-BSI2026-06-18
00850080243060Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-BSI2026-06-18
00850080243077Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-BSI2026-06-18
00850080243084Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2026-06-18
00850080243091Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2026-06-18
00850080243107Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2026-06-18
00850080243114Mg OSTEOINJECT® bone graft substitute5cc44-050-00-INJ2026-06-18
00850080243121Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2026-06-18
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
B4477120050Opus Mg Set BVF5cc7120052021-09-27
B4477120100Opus Mg Set BVF10cc7120102021-09-27
B4477120150Opus Mg Set BVF15cc7120152021-09-27
B4477121050Opus Mg Set BVF5cc7121052021-09-27

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