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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 K121514
Device Name ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
CORELINK LLC
1331 H STREET
12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
CORELINK LLC
1331 H STREET
12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/22/2012
Decision Date 12/14/2012
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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