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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K070181
Device Name SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
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 Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
KWQ  
Date Received01/19/2007
Decision Date 04/18/2007
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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