PMA P950019S004
- Device
- RAY TFC DEVICE WITH INSTRUMENTATION
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S004
- Product code
- MAX
- Decision date
- 1998-08-27
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Approval for modified labeling and labeling procedures for the instruments.
Current openFDA PMA Record#
- Device
- RAY TFC DEVICE WITH INSTRUMENTATION
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S004
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1998-08-27
- Decision code
- APPR
- Date received
- 1998-08-18
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modified labeling and labeling procedures for the instruments.