Mg OSTEOINJECT® bone graft substitute 44-100-00-INJ
GUDID B4474410000INJ0
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.
BONE SOLUTIONS, INC.
Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | B4474410000INJ0 |
| NIH Device Record Key | 2bc8bb85-d1fa-4b97-ab5e-c2d4c5544a81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mg OSTEOINJECT® bone graft substitute |
| Version Model Number | 10cc |
| Catalog Number | 44-100-00-INJ |
| Company DUNS | 003506272 |
| Company Name | BONE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net | |
| Phone | 8178098850 |
| customerservice@bonesolutions.net |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4474410000INJ0 [Primary] |
FDA Product Code
| MQV | Filler, Bone Void, Calcium Compound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-28 |
| Device Publish Date | 2024-05-20 |
Devices Manufactured by BONE SOLUTIONS, INC.
| B4474410000INJ0 - Mg OSTEOINJECT® bone graft substitute | 2024-05-28Mg 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. |
| B4474410000INJ0 - Mg OSTEOINJECT® bone graft substitute | 2024-05-28 Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive |
| B4474405000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474410000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474415000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474405000INJ0 - Mg OSTEOINJECT® Bone Void Filler | 2022-01-19 Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOINJECT® Bone Void Filler Packet contai |
| B4477120000 - Opus Mg Set - Mixing and Delivery System | 2021-10-05 The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft |
| B4477120010 - Mixing and Delivery System | 2021-10-05 The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft |
| B4477120050 - Opus Mg Set BVF | 2021-10-05 Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesiu |
Trademark Results [Mg OSTEOINJECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MG OSTEOINJECT 90779093 not registered Live/Pending |
Bone Solutions, Inc. 2021-06-17 |
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