PRODISC-C TOTAL DISC REPLACEMENT
FDA premarket approval P070001/S007 · decided 2010-07-02
Approval details
- PMA number
- P070001
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRODISC-C TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2010-06-02
- Decision date
- 2010-07-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- MODIFIED FIXTURE USED FOR INSPECTION OF THE PRODISC-C ENDPLATES.
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