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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAFFINITY (TM) CAGE SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral cervical device
Regulation Number888.3080
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP000028
Date Received07/11/2000
Decision Date06/13/2002
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 03M-0532
Notice Date 11/24/2003
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the affinity cage system. This device 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 
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