Data / Medical devices / United States / Biofusion Medical
Biofusion Medical: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
Biofusion Medical is registered with the FDA (registration 3015422154) in Austin, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015422154
- Address
- 4020 S Industrial Drive Ste 135, Austin, TX, United States, 78744
- Owner or operator
- Biofusion Medical (10059912)
- Roles
- Manufacturer
- First device listed
- March 7, 2019
- Registered through
- 2026
- Brand names listed
- SI-Restore
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 17, 2020 | K200868 | SI-Restore Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | Biofusion Medical | accessdata.fda.gov |
| January 25, 2019 | K182919 | SI-Restore® Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | Biofusion Medical | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2020. 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.