Data / Medical devices / Switzerland / Getset Surgical S.A.
Getset Surgical S.A.: FDA-registered device maker in Epalinges Vaud, Switzerland, 2 510(k) clearances
Getset Surgical S.A. is registered with the FDA (registration 3017780544) in Epalinges Vaud, Switzerland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2025. 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
- 3017780544
- Address
- Route de la Corniche 4, Epalinges Vaud, Switzerland, 1066
- Owner or operator
- GetSet Surgical (10080537)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 8, 2021
- Registered through
- 2026
- Brand names listed
- GoLIF! Lumbar Interbody Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K250186 | GoLIF! Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Getset Surgical, SA | accessdata.fda.gov |
| January 11, 2021 | K202505 | GetSet Surgical GoPLF! Posterior Lateral Fusion System | NKB | Substantially Equivalent | Getset Surgical, SA | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Thoracolumbosacral Pedicle Screw System
Updated March 21, 2025. 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.