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.
Summary
The SPINEART Navigation Instrument System is a set of trackable surgical instruments for use with computer-assisted spine surgery platforms. Product code OLO covers neurological-surgery navigation and related hardware — the instruments referenced here would pair with a navigation system from Medtronic, Brainlab, or similar to enable image-guided pedicle screw placement and related procedures.
Neurology panel, Special 510(k) — modification to a previously cleared Spineart navigation instrument line. Special pathway is common for navigation-instrument filings where the underlying tracking technology and workflow are unchanged.
Spineart SA files from Plan-Les-Ouates, Switzerland. Four-month review clock, longer than typical for Special.
Clearance details
- Applicant
- Spineart SA
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plan-Les-Ouates, CH
Adverse 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.