RAY THREADED FUSION CAGE(TFC)
FDA premarket approval P950019/S010 · decided 1999-12-01
Approval details
- PMA number
- P950019
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- RAY THREADED FUSION CAGE(TFC)
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 1999-09-27
- Decision date
- 1999-12-01
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Allendale, NJ
- Statement
- Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, Minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, Minnesota 55439 as an alternate site for assembly, packaging and labeling of the device.
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