CD Horizon Spinal System
FDA 510(k) clearance K211596 · decided 2021-06-23
Clearance details
- K-number
- K211596
- Device name
- CD Horizon Spinal System
- Applicant
- Medtronic
- Decision
- Substantially Equivalent
- Date received
- 2021-05-24
- Decision date
- 2021-06-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S230) | Medtronic | 2025-06-26 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S229) | Medtronic | 2025-06-05 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228) | Medtronic | 2025-06-04 |
| HeartWare HVAD System (P100047/S226) | Medtronic | 2025-05-05 |
| HeartWare® HVAD System (P100047/S225) | Medtronic | 2025-04-24 |
| HeartWare HVAD System (P100047/S224) | Medtronic | 2025-04-02 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222) | Medtronic | 2025-03-13 |