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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 K131242
Device Name ARDIS INTERBODY SYSTEM
Applicant
ZIMMER SPINE, INC
MINNEAPOLIS,  MN  55441
Applicant Contact JON GILBERT
Correspondent
ZIMMER SPINE, INC
MINNEAPOLIS,  MN  55441
Correspondent Contact JON GILBERT
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/01/2013
Decision Date 09/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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