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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 K091406
Device Name ATLAS SPINE SPACER
Applicant
Atlas Spine, LLC
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Applicant Contact JEANNETTE DAILEY
Correspondent
Atlas Spine, LLC
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Correspondent Contact JEANNETTE DAILEY
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
MAX  
Date Received05/12/2009
Decision Date 09/04/2009
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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