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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 K103491
Device Name SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact FRANK S JURCZAK
Correspondent
A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact FRANK S JURCZAK
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/26/2010
Decision Date 02/14/2011
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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