PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS
FDA premarket approval P090029/S007 · decided 2017-04-03
Approval details
- PMA number
- P090029
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2016-12-22
- Decision date
- 2017-04-03
- Days to decision
- 102 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the Prestige LP Cervical Disc streamlined instrument set, which primarily includes updates to the implant trial, drill guide, and rail punch instruments.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |