RAY TFC UNITE PRODUCT LINE
FDA premarket approval P950019/S013 · decided 2003-07-15
Approval details
- PMA number
- P950019
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- RAY TFC UNITE PRODUCT LINE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 2003-02-13
- Decision date
- 2003-07-15
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE. THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA.
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