Data / Medical devices / United States / Bone Solutions, Inc.
Bone Solutions, Inc.: FDA-registered device maker in Colleyville, TX, United States, 3 510(k) clearances
Bone Solutions, Inc. is registered with the FDA (registration 3008522639) in Colleyville, TX, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008522639
- Address
- 5712 Colleyville Blvd Ste 210, Colleyville, TX, United States, 76034
- Owner or operator
- Bone Solutions, Inc. (10033121)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 23, 2018
- Registered through
- 2026
- Brand names listed
- Mixing and Delivery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | OIS | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 13, 2025 | K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | MQV | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| February 18, 2020 | K192674 | Mixing and Delivery System | FMF | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| September 16, 2016 | K161568 | Bone Solutions Mixing and Delivery System | FMF | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- All makers of Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Syringe, Piston
- All makers of Orthopedic Manual Surgical Instrument
Updated October 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.