Clydesdale(R) Spinal System
by Medtronic Sofamor Danek USA, Inc. 2 variants
510(k) K113528
Clydesdale(R) Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K113528 on 20 Dec 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)SESE | NumberK113528 | Date20 Dec 2011 | StatusActive |
Official records
- FDA 510(k) database K113528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent