FDA Registration
Active
🇺🇸 United States
FOUNDATION FUSION SOLUTIONS, LLC
Reg #: 3013912820
·
FEI: 3013912820
·
Expires 2026
Products
8
Proprietary Names
2
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- FOUNDATION FUSION SOLUTIONS, LLC
- Registration Number
- 3013912820
- FEI Number
- 3013912820
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11916 S Oxford Ave, SUITE 206
- City
- Tulsa
- State
- OK
- ZIP
- 74137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211496
Owner / Operator
- Firm Name
- Foundation Fusion Solutions, LLC
- Operator Number
- 10058181
- Address
- 11916 S OXFORD AVE, SUITE 206
- City
- Tulsa
- State
- OK
- Postal Code
- 74137
- Country
- US
- Correspondent
- Robert Compton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2018-07-23 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-09-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-07-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-07-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2018-07-23 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2018-07-23 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2018-07-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2018-07-23 |
Proprietary Names
CornerLoc
TransLoc 3D
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198