T2 Spinal System
by Medtronic Sofamor Danek USA, Inc.
510(k) K091883
T2 Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K091883 on 21 Sep 2009, 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 | NumberK091883 | Date21 Sep 2009 | StatusActive |
Official records
- FDA 510(k) database K091883
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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