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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K112611
Device Name SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
Applicant
Sintea Plastek, LLC
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Applicant Contact DANIELLE WERNIKOWSKI
Correspondent
Sintea Plastek, LLC
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Correspondent Contact DANIELLE WERNIKOWSKI
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received09/07/2011
Decision Date 04/25/2012
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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