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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 K012000
Device Name 1.5MM BONE FIXATION KIT
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
Predetermined Change
Control Plan Authorized		 No
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