Beacon Stabilization System
by Globus Medical, Inc. 2 variants
510(k) K121922
Beacon Stabilization System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K121922 on 26 Jul 2012, 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 | NumberK121922 | Date26 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K121922
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- Withdrawn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