prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK
FDA premarket approval P070001/S028 · decided 2025-06-04
Approval details
- PMA number
- P070001
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2024-09-27
- Decision date
- 2025-06-04
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- Approval to add Fruh Exton, Pennsylvania as a second packaging location, and addition of a new STERIS (Isomedix Operations, Inc.) Chester, New York location to provide sterilization services
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 |