Data / Medical devices / United States / Pressio, Inc.
Pressio, Inc.: FDA-registered device maker in San Antonio, TX, United States, 1 510(k) clearance
Pressio, Inc. is registered with the FDA (registration 3019932366) in San Antonio, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3019932366
- Address
- 4600 Lockhill Selma Rd Ste 107, San Antonio, TX, United States, 78249
- Owner or operator
- Pressio, Inc. (10082513)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 5, 2021
- Registered through
- 2027
- Brand names listed
- CONTINUUM ACDF Staple System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anterior Staple As Supplemental Fixation For Fusion | PHQ | 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 |
|---|---|---|---|---|---|---|
| February 3, 2021 | K200301 | UNiTi ACDF Implant System | PHQ | Substantially Equivalent | Pressio, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 3, 2021. 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.