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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 K012001
Device Name SMARTSCREW
Applicant
BIONX IMPLANTS, LTD.
P.O. BOX 3
HERMINKATU 6-8L
TAMPERE,  FI SP-33721
Applicant Contact TUIJA ANNALA
Correspondent
BIONX IMPLANTS, LTD.
P.O. BOX 3
HERMINKATU 6-8L
TAMPERE,  FI SP-33721
Correspondent Contact TUIJA ANNALA
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received06/27/2001
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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