PMA P970015S030
- Device
- LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S030
- Product code
- MAX
- Decision date
- 2005-02-04
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS. SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS. THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.
Current openFDA PMA Record#
- Device
- LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S030
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2005-02-04
- Decision code
- APPR
- Date received
- 2004-11-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS. SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS. THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.