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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 K062782
Device Name INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
Applicant
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Applicant Contact KATI MARTTINEN
Correspondent
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Correspondent Contact KATI MARTTINEN
Regulation Number888.3030
Classification Product Code
MAI  
Date Received09/18/2006
Decision Date 11/09/2006
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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