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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K063464
Device Name ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Applicant
Atlas Spine, Inc.
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Applicant Contact JEANNETTE G DAILEY
Correspondent
Atlas Spine, Inc.
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Correspondent Contact JEANNETTE G DAILEY
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/16/2006
Decision Date 03/09/2007
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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