PMA P000028S001

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S001
Product code: MAX
Decision date: 2002-08-13
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order 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 DISC TO THE C7-T1 DISC. CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES. AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.

Current openFDA PMA Record#

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S001
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2002-08-13
Decision code: APPR
Date received: 2002-07-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 DISC TO THE C7-T1 DISC. CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES. AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.