PRODISC L TOTAL DISC REPLACEMENT
FDA premarket approval P050010/S003 · decided 2008-08-26
Approval details
- PMA number
- P050010
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRODISC L TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2008-07-28
- Decision date
- 2008-08-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- RELOCATION OF THE LASER ETCH MARKING.
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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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