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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K031961
Device Name INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
Applicant
INION LTD.
LAAKARINKATU 2
TAMPERE,  FI 33520
Applicant Contact HANNA MARTTILA
Correspondent
INION LTD.
LAAKARINKATU 2
TAMPERE,  FI 33520
Correspondent Contact HANNA MARTTILA
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/25/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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