RAY TFC DEVICE WITH INSTRUMENTATION
FDA premarket approval P950019/S004 · decided 1998-08-27
Approval details
- PMA number
- P950019
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RAY TFC DEVICE WITH INSTRUMENTATION
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 1998-08-18
- Decision date
- 1998-08-27
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- Approval for modified labeling and labeling procedures for the instruments.
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