VERTICALE Navigation Instruments
510(k) K212007
VERTICALE Navigation Instruments is a Class II device made by Silony Medical GmbH, cleared under FDA 510(k) K212007 on 12 Aug 2021, 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 | NumberK212007 | Date12 Aug 2021 | StatusActive |
Official records
- FDA 510(k) database K212007
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- Withdrawn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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