RAY TFC DEVICE/RAY TFC UNITE DEVICE
FDA premarket approval P950019/S012 · decided 2002-04-02
Approval details
- PMA number
- P950019
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAY TFC DEVICE/RAY TFC UNITE DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 2002-02-11
- Decision date
- 2002-04-02
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- APPROVAL FOR ADDITIONAL INSTRUMENTS FOR THE ALIF-OPEN SURGICAL TECHNIQUE FOR THE RAY TFC AND RAY TFC UNITE DEVICES AND REVISED LABELING.
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