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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 Interlaminal
510(k) Number K060513
Device Name SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
Applicant
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Applicant Contact GUSTAVO A RIOS
Correspondent
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Correspondent Contact GUSTAVO A RIOS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received02/27/2006
Decision Date 03/10/2006
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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