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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 K112206
Device Name CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Applicant Contact DAN MILLER
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Correspondent Contact DAN MILLER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/01/2011
Decision Date 01/25/2012
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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