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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 K993074
Device Name SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
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 Number888.3030
Classification Product Code
MAI  
Date Received09/14/1999
Decision Date 12/10/1999
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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