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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 K082037
Device Name SEEPLATE CERVICAL PLATE SYSTEM
Applicant
Amedica Corp.
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact ADAM HERDER
Correspondent
Amedica Corp.
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact ADAM HERDER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/17/2008
Decision Date 09/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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