RAY TFC UNITE
FDA premarket approval P950019/S016 · decided 2003-10-10
Approval details
- PMA number
- P950019
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RAY TFC UNITE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 2003-09-26
- Decision date
- 2003-10-10
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- APPROVAL FOR LABELING CHANGES (CHANGE OF ADDRESS, CHANGE IN CE MARK, ADDITIONAL PATENT STATEMENT) AND CHANGES IN PART NUMBERS.
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