Data / Medical devices / United States / Foundation Fusion Solutions, LLC
Foundation Fusion Solutions, LLC: FDA-registered device maker in Tulsa, OK, United States, 1 510(k) clearance
Foundation Fusion Solutions, LLC is registered with the FDA (registration 3013912820) in Tulsa, OK, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013912820
- Address
- 11916 S Oxford Ave SUITE 206, Tulsa, OK, United States, 74137
- Owner or operator
- Foundation Fusion Solutions, LLC (10058181)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 23, 2018
- Registered through
- 2026
- Brand names listed
- CornerLoc, TransLoc 3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 27, 2022 | K211496 | TransLoc 3D | OUR | Substantially Equivalent | Foundation Fusion Solutions, LLC (Dba Cornerloc) | accessdata.fda.gov |
Compare with other makers
- All makers of Extractor
- All makers of Driver, Prosthesis
- All makers of Broach
- All makers of Sacroiliac Joint Fixation
- All makers of Bit, Drill
- All makers of Guide, Surgical, Instrument
Updated July 27, 2022. 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.