Range, Spinal System, Everest Spinal System
by K2M, Inc.
510(k) K133944
Range, Spinal System, Everest Spinal System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K133944 on 21 Mar 2014, 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 | NumberK133944 | Date21 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent