CD Horizon™ Astute™ Spinal System 1608451080
by Medtronic Sofamor Danek, Inc.
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000313029 | Date9 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191066 | Date3 Oct 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CD Horizon™ Astute™ Spinal System
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 1608451080
- Primary DI / UDI-DI
- 00763000313029
- 510(k) Number
- FDA product code
- KWP, NQP, KWQ, NKB
- 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
- Outer Diameter — 80.0 MillimeterLength — 6.0 MillimeterWidth — 6.9 Millimeter
Other devices from Medtronic Sofamor Danek, Inc.
Properties
Other properties (10)
- Sterilise before use: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No