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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 K080411
Device Name PLATEAU SPACER SYSTEM
Applicant
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Applicant Contact REBECCA M BROOKS
Correspondent
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Correspondent Contact REBECCA M BROOKS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/15/2008
Decision Date 05/15/2008
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
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