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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 K152455
Device Name Amendia Cervical Plate System
Applicant
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Applicant Contact Kristen Allen
Correspondent
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Correspondent Contact Kristen Allen
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/28/2015
Decision Date 10/15/2015
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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