PMA P970015S025
- Device
- INTER FIX THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S025
- Product code
- MAX
- Decision date
- 2003-09-17
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE APPROVED POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- INTER FIX THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S025
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2003-09-17
- Decision code
- APPR
- Date received
- 2003-08-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE APPROVED POST-APPROVAL STUDY.