PRESTIGE LP Cervical Disc
FDA premarket approval P090029/S010 · decided 2018-09-27
Approval details
- PMA number
- P090029
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRESTIGE LP Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2018-09-18
- Decision date
- 2018-09-27
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for modifications to the Prestige LP Streamlined Instrument labeling (surgical technique document) to reference new drill bits to be used with the system to enhance the safe use of the device.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |