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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K090343
Device Name SENTINEL SPINAL SYSTEM
Applicant
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Applicant Contact MURALI AUDIPUDY
Correspondent
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Correspondent Contact MURALI AUDIPUDY
Regulation Number888.3050
Classification Product Code
KWP  
Date Received02/10/2009
Decision Date 08/11/2009
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
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