PMA P000028S006
- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S006
- Product code
- MAX
- Decision date
- 2004-08-24
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.
Current openFDA PMA Record#
- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S006
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2004-08-24
- Decision code
- OK30
- Date received
- 2004-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.