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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 K032894
Device Name OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
Applicant
Linvatec Biomaterials, Inc.
P.O. Box 3
Hermiankatu 6-8l
Tampere,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
Linvatec Biomaterials, Inc.
P.O. Box 3
Hermiankatu 6-8l
Tampere,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/17/2003
Decision Date 05/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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