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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K073202
Device Name ARDIS SPACER
Applicant
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG F
AUSTIN,  TX  78727
Applicant Contact MARITZA ELIAS
Correspondent
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG F
AUSTIN,  TX  78727
Correspondent Contact MARITZA ELIAS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/13/2007
Decision Date 01/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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