PMA P970015S028
- Device
- INTER FIX THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S028
- Product code
- MAX
- Decision date
- 2004-07-19
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE INTER FIX THREADED FUSION DEVICE.
Current openFDA PMA Record#
- Device
- INTER FIX THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S028
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2004-07-19
- Decision code
- OK30
- Date received
- 2004-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE INTER FIX THREADED FUSION DEVICE.