AFFINITY (TM) CAGE SYSTEM

FDA Premarket Approval P000028

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

DeviceAFFINITY (TM) CAGE SYSTEM
Generic NameIntervertebral Fusion Device With Bone Graft, Lumbar
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2000-07-11
Decision Date2002-06-13
Notice Date2003-11-24
PMAP000028
SupplementS
Product CodeMAX 
Docket Number03M-0532
Advisory CommitteeOrthopedic
Expedited ReviewYes
Combination Product No
Applicant Address Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P000028Original Filing
S008 2006-04-20 Normal 180 Day Track No User Fee
S007
S006 2004-07-30 30-day Notice
S005 2004-05-19 Special (immediate Track)
S004 2003-08-27 Normal 180 Day Track No User Fee
S003 2002-11-08 Normal 180 Day Track
S002 2002-07-15 Normal 180 Day Track
S001 2002-07-09 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00721902307867 P000028 000
00721902307676 P000028 000
00721902307690 P000028 000
00721902307706 P000028 000
00721902307713 P000028 000
00721902307737 P000028 000
00721902307775 P000028 000
00721902307782 P000028 000
00721902307805 P000028 000
00721902307829 P000028 000
00721902307836 P000028 000
00721902307843 P000028 000
00721902307850 P000028 000
00721902307652 P000028 000

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