SPINEART Navigation Instrument System— 510(k) K254158
Substantially EquivalentSpineart SA
FDA 510(k) clearance K254158 for SPINEART Navigation Instrument System, Substantially Equivalent on 2026-04-09. Applicant: Spineart SA. Device class: 2.
Summary
The SPINEART Navigation Instrument System is a set of instruments for navigated spine surgery, filed under OLO, orthopedic stereotaxic instruments. A separate navigation system tracks instruments like these so the surgeon can see their position against the patient's imaging.
Class II, 21 CFR 882.4560, Neurology panel. It's a Special 510(k), meaning Spineart was modifying instruments it already had cleared.
Spineart filed from Plan-les-Ouates, near Geneva, Switzerland. Review took 108 days (December 22, 2025 to April 9, 2026), longer than a Special usually takes.
Clearance details
- Applicant
- Spineart SA
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plan-Les-Ouates, CH
Recent devices under product code OLO
view allMore clearances from Spineart SA
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.