CD HORIZON® Spinal System 8100845
by Medtronic Sofamor Danek, Inc.
CD HORIZON® Spinal System 8100845 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061579 on 11 Aug 2006 and listed in FDA GUDID since 15 Jul 2015 (UDI-DI 00613994154873), active as of 23 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 | Number00613994154873 | Date15 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061579 | Date11 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00613994154873
- FDA 510(k) database K061579
Across registries
- FDA 510(k) K061579 decided 11 Aug 2006 Active
- FDA GUDID UDI-DI 00613994154873 listed 15 Jul 2015 Listed
Timeline
- Cleared FDA 510(k) K061579
- Listed FDA GUDID 00613994154873
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CD HORIZON® Spinal System
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 8100845
- Primary DI / UDI-DI
- 00613994154873
- 510(k) Number
- FDA product code
- KWP, KWQ, MNH, NQP, NKB, MNI
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3050, 888.3060, 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Spinal bone screw, non-bioabsorbable.