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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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