RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
FDA premarket approval P950019 · decided 1996-10-29
Approval details
- PMA number
- P950019
- Trade name
- RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Stryker Spine
- Date received
- 1995-06-14
- Decision date
- 1996-10-29
- Days to decision
- 503 days
- Decision code
- APRL
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Allendale, NJ
- Statement
- APPROVAL FOR THE RAY THREADED FUSION CAGE (TFC) WITH INSTRUMENTATION
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