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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K072198
Device Name X-VOID, SPIDER
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 Number888.1100
Classification Product Code
HRX  
Subsequent Product Codes
HXG   OAR  
Date Received08/07/2007
Decision Date 06/06/2008
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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