PRODISC-C TOTAL DISC REPLACEMENT
FDA premarket approval P070001/S004 · decided 2011-01-14
Approval details
- PMA number
- P070001
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRODISC-C TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2010-05-19
- Decision date
- 2011-01-14
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.
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510(k) clearances by this applicant
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|---|---|---|
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
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