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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 K071464
Device Name INION HEXALON BIODEGRADABLE ACL/PCL SCREW
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 Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MAI  
Date Received05/29/2007
Decision Date 08/03/2007
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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