PMA P950019S009
- Device
- RAY TFC DEVICE AND RAY TFC UNITE DEVICE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S009
- Product code
- MAX
- Decision date
- 2000-03-02
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950019S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- RAY TFC DEVICE AND RAY TFC UNITE DEVICE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S009
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2000-03-02
- Decision code
- APPR
- Date received
- 1999-05-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1.