SYNTHES PRODISC-C TOTAL DISC REPLACEMENT
FDA premarket approval P070001/S013 · decided 2014-08-27
Approval details
- PMA number
- P070001
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNTHES PRODISC-C TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2014-04-03
- Decision date
- 2014-08-27
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.
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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 |