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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 K042966
Device Name DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
Applicant
Linvatec Biomaterials, Ltd.
Hermiankatu 6-8l
Tampere,  FI
Applicant Contact TUIJA ANNALA
Correspondent
Linvatec Biomaterials, Ltd.
Hermiankatu 6-8l
Tampere,  FI
Correspondent Contact TUIJA ANNALA
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
JDR  
Date Received10/28/2004
Decision Date 11/19/2004
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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