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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K140236
Device Name AILERON INTERSPINOUS FIXATION SYSTEM
Applicant
Life Spine, Inc.
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Applicant Contact RANDY LEWIS
Correspondent
Life Spine, Inc.
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Correspondent Contact RANDY LEWIS
Regulation Number888.3050
Classification Product Code
PEK  
Date Received01/30/2014
Decision Date 10/20/2014
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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