K2M Growing Spine System
by K2M, Inc.
510(k) K161028
K2M Growing Spine System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K161028 on 22 Jul 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 | NumberK161028 | Date22 Jul 2016 | StatusActive |
Official records
- FDA 510(k) database K161028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PGM
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent