PRODISC L
FDA premarket approval P050010/S027 · decided 2025-09-02
Approval details
- PMA number
- P050010
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRODISC L
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2025-06-20
- Decision date
- 2025-09-02
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- approval of an alternate manufacturing site, Summit Orthopedic Technologies Inc. (FEI 3012491394) for machining, cleaning, and passivation of the Prodisc L implants
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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 |