AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
FDA premarket approval P000028/S001 · decided 2002-08-13
Approval details
- PMA number
- P000028
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2002-07-09
- Decision date
- 2002-08-13
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) MINOR DESIGN CHANGES TO THE CAGE, MAINLY CONSISTING OF MINOR CHANGES TO THE THREADS; 2) PROVIDE THE DEVICE STERILE; AND 3) CHANGE THE DEVICE NAME TO THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFFINITY ANTERIOR CERVICAL CAGE SYSTEM AND IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3
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