FDA.reportPublic FDA data

Mg OSTEOCRETE™ bone graft substitute

Primary DI
B4474410000STR0
Brand
Mg OSTEOCRETE™ bone graft substitute
Company
BONE SOLUTIONS, INC.
Model
10cc
Catalog number
44-100-00-STR
Device description
Mg OSTEOCRETE™ 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 OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
Published
2020-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
B4474410000STR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile 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 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 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
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
B4477120050Opus Mg Set BVF5cc7120052021-09-27
B4477120100Opus Mg Set BVF10cc7120102021-09-27
B4477120150Opus Mg Set BVF15cc7120152021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01