CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
FDA 510(k) clearance K153442 · decided 2016-02-18
Clearance details
- K-number
- K153442
- Device name
- CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-27
- Decision date
- 2016-02-18
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE® Bone Graft (P000054/S074) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S093) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| INFUSE Bone Graft (P000054/S073) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| Prestige LP (R) Cervical Disc (P090029/S021) | Medtronic Sofamor Danek USA, Inc. | 2024-08-09 |
| Prestige LP (R) Cervical Disc (P090029/S020) | Medtronic Sofamor Danek USA, Inc. | 2024-05-01 |
| Prestige LP Cervical Disc (P090029/S018) | Medtronic Sofamor Danek USA, Inc. | 2024-02-21 |
| Prestige LP® Cervical Disc (P090029/S019) | Medtronic Sofamor Danek USA, Inc. | 2023-10-26 |