prodisc - C and prodisc - C Nova (Indicated for Single Level Use)
FDA premarket approval P070001/S026 · decided 2024-03-01
Approval details
- PMA number
- P070001
- Supplement
- S026
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- prodisc - C and prodisc - C Nova (Indicated for Single Level Use)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2024-02-06
- Decision date
- 2024-03-01
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- Approval for modification to the device labeling to include the addition of the following precaution statement: Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.
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 |
|---|---|---|
| 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 |