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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 K140361
Device Name META-C CERVICAL PLATE
Applicant
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Applicant Contact ADAM GROSS
Correspondent
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Correspondent Contact ADAM GROSS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/12/2014
Decision Date 06/12/2014
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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