510(k) K254158
- Device
- SPINEART Navigation Instrument System
- Applicant
- Spineart SA
- 510(k) number
- K254158
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-09
- Date received
- 2025-12-22
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Estelle Lefeuvre
- Address
- Chemin Du Pré-Fleuri 3 Plan-Les-Ouates CH 1228 1228
FDA Registration Numbers
- 1450662
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 |
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