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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, Cervical
510(k) Number K093093
Device Name SMALL PLATEAU SPACER SYSTEM
Applicant
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Applicant Contact CHARLES P GILL
Correspondent
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Correspondent Contact CHARLES P GILL
Regulation Number888.3080
Classification Product Code
ODP  
Date Received10/01/2009
Decision Date 10/13/2010
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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