Data / Medical devices / Mexico / Fixier S.A. De C.V.
Fixier S.A. De C.V.: FDA-registered device maker in Doctor Mora Guanajuato, Mexico, 1 510(k) clearance
Fixier S.A. De C.V. is registered with the FDA (registration 3022777867) in Doctor Mora Guanajuato, Mexico. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 18, 2022. 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
- 3022777867
- Address
- Carretera Doctor Mora a San Miguel de Allende km 3.4 Comunidad de San Rafael, Doctor Mora Guanajuato, Mexico, 37967
- Owner or operator
- Fixier S.A. de C.V. (10085082)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 10, 2022
- Registered through
- 2026
- Brand names listed
- 2.5mm titanium cortex locking screw 10mm, Torx drive, code 155.10X, 2.5mm titanium cortex locking screw 12mm, Torx drive, code 155.12X, 2.5mm titanium cortex locking screw 14mm, Torx drive, code 155.14X, 2.5mm titanium cortex locking screw 20mm, Torx drive, code 155.20X, 2.5mm titanium cortex locking screw 22mm, Torx drive, code 155.22X, 2.5mm titanium cortex locking screw 24mm, Torx drive, code 155.24X, 2.5mm titanium cortex locking screw 26mm, Torx drive, code 155.26X, 2.5mm titanium cortex locking screw 28mm, Torx drive, code 155.28X and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 18, 2022 | K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | HRS | Substantially Equivalent | Fixier S.A. DE C.V. | accessdata.fda.gov |
Compare with other makers
Updated February 18, 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.