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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K091069
Device Name MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
Applicant
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact NATALIE J KENNEL
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JWH  
Date Received04/14/2009
Decision Date 06/01/2009
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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