RAY TFC AND RAY TFC UNITE
FDA premarket approval P950019/S014 · decided 2004-03-25
Approval details
- PMA number
- P950019
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- RAY TFC AND RAY TFC UNITE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 2003-02-13
- Decision date
- 2004-03-25
- Days to decision
- 406 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRYKER SPINE, CESTAS, FRANCE.
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