Spine Navigation System
510(k) K233725
Spine Navigation System is a medical device (FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument) made by Medivis, Inc., cleared under FDA 510(k) K233725 on 26 Jul 2024, 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 | NumberK233725 | Date26 Jul 2024 | StatusActive |
Official records
- FDA 510(k) database K233725
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- Withdrawn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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