RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION
FDA premarket approval P950019/S007 · decided 1999-03-19
Approval details
- PMA number
- P950019
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 1999-02-18
- Decision date
- 1999-03-19
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- Approval for modified device outer box labels.
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