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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K061954
Device Name ARTELON CMC SPACER ARTHRO
Applicant
Artimplant AB
719 A St. NE
Washington,  DC  20002
Applicant Contact RUSSELL PAGANO
Correspondent
Artimplant AB
719 A St. NE
Washington,  DC  20002
Correspondent Contact RUSSELL PAGANO
Regulation Number888.3770
Classification Product Code
KYI  
Date Received07/11/2006
Decision Date 06/01/2007
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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