CD Horizon® Spinal System 1553301050
by Medtronic Sofamor Danek, Inc.
CD Horizon® Spinal System 1553301050 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K202328 on 8 Sep 2020 and listed in FDA GUDID since 17 Oct 2020 (UDI-DI 00643169026759), 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 | GUDID listing | Number00643169026759 | Date17 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202328 | Date8 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 00643169026759
- FDA 510(k) database K202328
Across registries
- FDA 510(k) K202328 decided 8 Sep 2020 Active
- FDA GUDID UDI-DI 00643169026759 listed 17 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K202328
- Listed FDA GUDID 00643169026759
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CD Horizon® Spinal System
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 1553301050
- Primary DI / UDI-DI
- 00643169026759
- 510(k) Number
- FDA product code
- KWP, NKB, KWQ
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070, 888.3060
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 50.0 MillimeterOuter Diameter — 5.5 Millimeter