Spine & Trauma Navigation
510(k) K191285
Spine & Trauma Navigation is a Class II device made by Brainlab AG, cleared under FDA 510(k) K191285 on 11 Jun 2019, 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 | NumberK191285 | Date11 Jun 2019 | StatusActive |
Official records
- FDA 510(k) database K191285
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- Withdrawn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