FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SPINEART Navigation Instrument System
K Number: K254158
·
Decision Apr 9, 2026
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
11
Review Days
108
Basic Information
- Device Name
- SPINEART Navigation Instrument System
- K Number
- K254158
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineart SA
- Date Received
- December 22, 2025
- Decision Date
- April 9, 2026
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Spineart SA
| K Number | Device Name | ||
|---|---|---|---|
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | May 1, 2026 | Substantially Equivalent |
| K242933 | SPINEART Navigation Instrument System | Jun 18, 2025 | Substantially Equivalent |
| K242890 | SPINEART Navigation Instrument System | Mar 7, 2025 | Substantially Equivalent |
| K242589 | Scarlet® AL-T | Oct 23, 2024 | Substantially Equivalent |
| K241644 | SPINEART Navigation Instrument System | Aug 7, 2024 | Substantially Equivalent |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Jul 18, 2024 | Substantially Equivalent |
| K240699 | SCARLET® AC-Ti | May 10, 2024 | Substantially Equivalent |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Oct 25, 2023 | Substantially Equivalent |
| K230583 | Tryptik Ti | Mar 22, 2023 | Substantially Equivalent |
| K183630 | SPINEART Navigation Instrument System | Jun 10, 2019 | Substantially Equivalent |