PRODISC-L TOTAL DISC REPLACEMENT
FDA premarket approval P050010/S001 · decided 2008-01-25
Approval details
- PMA number
- P050010
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRODISC-L TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2007-12-26
- Decision date
- 2008-01-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR NEW POLYETHYLENE INLAYS WITH A TANTALUM RADIOGRAPHIC MARKER EMBEDDED IN THE ANTERIOR LIP OF THE INLAY.
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510(k) clearances by this applicant
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|---|---|---|
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
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