prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo
FDA premarket approval P070001/S019 · decided 2022-07-07
Approval details
- PMA number
- P070001
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2020-12-18
- Decision date
- 2022-07-07
- Days to decision
- 566 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- Approval for a Line Extension to Centinel Spines prodisc® C: the prodisc® C SK, the prodisc® C Nova, and the prodisc® C Vivo.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
| prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) | Centinel Spine, LLC | 2022-08-19 |