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 filed under OLO, orthopedic stereotaxic instruments. The code covers stereotaxic guidance during orthopedic joint or spine surgery. The record doesn't list the instruments.
Class II, 21 CFR 882.4560, filed as a Special 510(k). The record lists Neurology as the advisory panel and Orthopedic as the review panel.
Spineart filed from Plan-les-Ouates, Switzerland. Review took 108 days (December 22, 2025 to April 9, 2026).
Clearance details
- Applicant
- Spineart SA
- Product code
- Product 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.