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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 Intervertebral Body
510(k) Number K040844
Device Name LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
Applicant
LIFE SPINE, LLC.
11965 EAST 65TH ST. SUITE 4
INDIANAPOLIS,  IN  46236
Applicant Contact MICHAEL S BUTLER
Correspondent
LIFE SPINE, LLC.
11965 EAST 65TH ST. SUITE 4
INDIANAPOLIS,  IN  46236
Correspondent Contact MICHAEL S BUTLER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/01/2004
Decision Date 07/23/2004
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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