Data / Medical devices / United States / Presidio Surgical, Inc.
Presidio Surgical, Inc.: FDA-registered device maker in New Braunfels, TX, United States, 2 510(k) clearances
Presidio Surgical, Inc. is registered with the FDA (registration 3012381896) in New Braunfels, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012381896
- Address
- 202 Northridge, New Braunfels, TX, United States, 78132
- Owner or operator
- Presidio Surgical, Inc. (10052031)
- Roles
- Manufacturer
- First device listed
- June 2, 2016
- Registered through
- 2026
- Brand names listed
- Viking Lumbar Polyaxial Screw System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 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 |
|---|---|---|---|---|---|---|
| July 13, 2018 | K180655 | Viking Lumbar Polyaxial Screw System | NKB | Substantially Equivalent | Presidio Surgical | accessdata.fda.gov |
| May 18, 2012 | K120091 | R&D INNOVATION PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | R&D Innovation, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
Updated July 13, 2018. 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.