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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 K123100
Device Name INTESS LUMBAR CAGE
Applicant
Kalitec Direct, LLC
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J D WEBB
Correspondent
Kalitec Direct, LLC
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J D WEBB
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/02/2012
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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