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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K000616
Device Name SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
Applicant
Bionx Implants, Ltd.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
Bionx Implants, Ltd.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received02/24/2000
Decision Date 03/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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