PRESTIGE LP CERVICAL DISC
FDA premarket approval P090029 · decided 2014-07-24
Approval details
- PMA number
- P090029
- Trade name
- PRESTIGE LP CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2009-12-22
- Decision date
- 2014-07-24
- Days to decision
- 1675 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE PRESTIGE® LP CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Catalyft PL Expandable Interbody System (K253011) | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
| Symmetrix™ L Spinal System (K261020) | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656) | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216) | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| Infinity™ OCT System (K254165) | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 |
| CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |