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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 K021280
Device Name INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Applicant
Inion , Ltd.
Laakarinkatu2
Tampere,  FI FIN-33520
Applicant Contact HANNA MARTTILA
Correspondent
Inion , Ltd.
Laakarinkatu2
Tampere,  FI FIN-33520
Correspondent Contact HANNA MARTTILA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/22/2002
Decision Date 07/17/2002
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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