PMA P000028S002
- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S002
- Product code
- MAX
- Decision date
- 2002-12-03
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL 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
- S002
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2002-12-03
- Decision code
- APPR
- Date received
- 2002-07-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.