VERTICALE® Navigation Instruments— 510(k) K253921
Substantially EquivalentSilony Medical GmbH
FDA 510(k) clearance K253921 for VERTICALE® Navigation Instruments, Substantially Equivalent on 2026-06-26. Applicant: Silony Medical GmbH. Device class: 2.
Summary
Silony Medical's VERTICALE Navigation Instruments are filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the individual instruments.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Silony filed from Leinfelden-Echterdingen, Germany. Review took 200 calendar days (December 8, 2025 to June 26, 2026).
Clearance details
- Applicant
- Silony Medical GmbH
- 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
- Traditional
- Location
- Leinfelden-Echterdingen, DE
Recent devices under product code OLO
view allMore clearances from Silony Medical GmbH
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.