FDA Registration
Active
🇺🇸 United States
BONE SOLUTIONS, INC.
Reg #: 3008522639
·
FEI: 3008522639
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- BONE SOLUTIONS, INC.
- Registration Number
- 3008522639
- FEI Number
- 3008522639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5712 Colleyville Blvd Ste 210
- City
- Colleyville
- State
- TX
- ZIP
- 76034
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192674
Owner / Operator
- Firm Name
- Bone Solutions, Inc.
- Operator Number
- 10033121
- Address
- 5712 Colleyville Blvd., Suite 210
- City
- Colleyville
- State
- TX
- Postal Code
- 76034
- Country
- US
- Correspondent
- Drew Diaz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-02-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-10-05 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2026-01-07 |
| Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | OIS | Class 2 | Orthopedic | No | 2026-01-07 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2026-01-07 |
Proprietary Names
Mixing and Delivery System
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device