FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERTICALE GPS Instruments
K Number: K254148
·
Decision Feb 19, 2026
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
12
Review Days
59
Basic Information
- Device Name
- VERTICALE GPS Instruments
- K Number
- K254148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Silony Medical GmbH
- Date Received
- December 22, 2025
- Decision Date
- February 19, 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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| K Number | Device Name | ||
|---|---|---|---|
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| K212007 | VERTICALE Navigation Instruments | Aug 12, 2021 | Substantially Equivalent |
| K192013 | VERTICALE® Cervical System | Apr 7, 2020 | Substantially Equivalent |
| K190680 | FAVO S-TLIF | Jul 18, 2019 | Substantially Equivalent |
| K182608 | Oyster ACIF Cage | Jun 13, 2019 | Substantially Equivalent |
| K181899 | ROCCIA® PLIF | Dec 13, 2018 | Substantially Equivalent |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | Jul 11, 2018 | Substantially Equivalent |
| K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | Jan 10, 2018 | Substantially Equivalent |
| K171434 | ROCCIA® MultiLIF | Dec 21, 2017 | Substantially Equivalent |