Idys™ TLIF TiVac
510(k) K183259
Idys™ TLIF TiVac is a Class II device made by Clariance, Sas, cleared under FDA 510(k) K183259 on 1 Mar 2019, active as of 25 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 | NumberK183259 | Date1 Mar 2019 | StatusActive |
Official records
- FDA 510(k) database K183259
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent