PMA P000028

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S008
Product code: MAX
Decision date: 2006-07-25
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE.

Current openFDA PMA Record#

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S008
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2006-07-25
Decision code: APPR
Date received: 2006-04-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE.