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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K050275
FOIA Releasable 510(k) K050275
Device Name MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
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 Number888.3040
Classification Product Code
HTY  
Date Received02/07/2005
Decision Date 03/07/2005
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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