PRESTIGE: LP(TM) CERVICAL DISC
FDA premarket approval P090029/S008 · decided 2018-01-31
Approval details
- PMA number
- P090029
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRESTIGE: LP(TM) CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2017-07-13
- Decision date
- 2018-01-31
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for manufacturing sites located at MedTorque, Inc., 612 W. Lamont Road, Elmhurst, Illinois, for instrument machining and laser marking of the BRYAN and PRESTIGE LP instruments, and at Medtronic Sofamor Danek USA, Inc., 4340 Swinnea Road, Memphis, Tennessee, for the manufacturing of PRESTIGE LP Streamlined Instrument.
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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 |