VERTICALE® Navigation Instruments
by Silony Medical GmbH 2 variants
510(k) K223649
VERTICALE® Navigation Instruments is a Class II device made by Silony Medical GmbH, cleared under FDA 510(k) K223649 on 22 Dec 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223649 | Date22 Dec 2022 | StatusActive |
Official records
- FDA 510(k) database K223649
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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