Cascadia Interbody System
by K2m 3 variants
510(k) K160125
Cascadia Interbody System is a Class II device made by K2m, cleared under FDA 510(k) K160125 on 22 Apr 2016, 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 | NumberK160125 | Date22 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K160125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent