bonesolutions.netMg OSTEOREVIVE?, Mg OSTEOCRETE?
Bone Solutions, Inc.
BONE SOLUTIONS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008522639 | 3008522639 | BONE SOLUTIONS, INC. | 1 | N | 2026-01-01 | 5712 Colleyville Blvd Ste 210 Colleyville TX US 76034 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850080243145 | T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | 8178098850 | customerservice@bonesolutions.net |
| 00850080243152 | T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | 8178098850 | customerservice@bonesolutions.net |
| 00850080243169 | T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | 8178098850 | customerservice@bonesolutions.net |
| B4474405000INJ0 | Mg OSTEOINJECT® bone graft substitute - 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. | 8178098850 | customerservice@bonesolutions.net |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 119161 | 1821426130 | K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | MQV | 2025-10-13 |
| 119161 | 1143190980 | K192674 | Mixing and Delivery System | FMF | 2020-02-18 |
| 119161 | 1590785135 | K161568 | Bone Solutions Mixing and Delivery System | FMF | 2016-09-16 |
| 119161 | 1038347074 | K071004 | OSTEOCRETE BONE VOID FILLER | MQV | 2009-05-21 |
| 119161 | 1317546202 |
Product Codes Associated With Registrations#
PMN#
Mg OSTEOINJECT?; Mg OSTEOREVIVE?; Mg OSTEOCRETE?
Bone Solutions, Inc.
Mg OSTEOINJECT
Bone Solutions, Inc.
Osteorevive
Bone Solutions, Inc.
Mixing And Delivery System
Bone Solutions, Inc.
Bone Solutions Mixing And Delivery System
BONE SOLUTIONS, INC.
OSTEOCRETE BONE VOID FILLER
BONE SOLUTIONS, INC.
GUDID#
T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2026-02-13
T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2026-02-13
T-Han Delivery System - The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2026-02-13
Mg OSTEOINJECT® bone graft substitute - 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.
2024-05-20
Mg OSTEOREVIVE™ bone graft substitute - Mg OSTEOREVIVE™ 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 OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
2022-02-02
Mg OSTEOREVIVE™ bone graft substitute - Mg OSTEOREVIVE™ 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 OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
2022-02-02
Mg OSTEOREVIVE™ bone graft substitute - Mg OSTEOREVIVE™ 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 OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
2022-02-02
Mg OSTEOINJECT® bone graft substitute - 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.
2022-01-11
Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2021-09-27
Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2020-07-30
Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2020-07-30
Mg OSTEOCRETE™ bone graft substitute - 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.
2020-02-19
Mg OSTEOCRETE™ bone graft substitute - 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.
2020-02-19
Mg OSTEOCRETE™ bone graft substitute - 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.
2020-02-19
Mg OSTEOCRETE™ bone graft substitute - 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.
2020-02-19
Mg OSTEOCRETE™ bone graft substitute - 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.
2020-02-19
Mg OSTEOCRETE™ bone graft substitute - 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.
2017-08-04
Opus Mg Set - Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Opus Mg Set BVF - 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.
2021-09-27
Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2020-02-20
Mixing and Delivery System - The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
2020-07-30
OsteoCrete® Bone Void Filler - OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler 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.
2017-08-04
OsteoCrete® Bone Void Filler - OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler 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.
2017-08-04