Tsrh Spinal Systems
by Medtronic Sofamor Danek USA, Inc.
510(k) K111942
Tsrh Spinal Systems is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K111942 on 30 Aug 2011, 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)SESU | NumberK111942 | Date30 Aug 2011 | StatusActive |
Official records
- FDA 510(k) database K111942
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- Withdrawn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
- SESU