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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 K112861
Device Name SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
Applicant
SINTEA PLUSTEK, LLC
407 LINCOLN ROAD, SUITE 10L
MIAMI BEACH,  FL  33139
Applicant Contact DANIELLE WERNIKOWSKI
Correspondent
SINTEA PLUSTEK, LLC
407 LINCOLN ROAD, SUITE 10L
MIAMI BEACH,  FL  33139
Correspondent Contact DANIELLE WERNIKOWSKI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/30/2011
Decision Date 02/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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