Navigated INFINITY Instruments
by Medtronic Sofamor Danek USA, Inc.
510(k) K181111
Navigated INFINITY Instruments is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K181111 on 17 May 2018, 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 | NumberK181111 | Date17 May 2018 | StatusActive |
Official records
- FDA 510(k) database K181111
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- Withdrawn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