Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
FDA 510(k) clearance K191148 · decided 2019-09-12
Clearance details
- K-number
- K191148
- Device name
- Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-30
- Decision date
- 2019-09-12
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- PML
- Device class
- 2
- Regulation number
- 888.3027
- 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 |