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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 K081392
Device Name BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
Applicant
BIORETEC LTD
HERMIANKATU 22 MODULIGHT BLDG
TAMPERE,  FI FI-33720
Applicant Contact MARI RUOTSALAINEN
Correspondent
BIORETEC LTD
HERMIANKATU 22 MODULIGHT BLDG
TAMPERE,  FI FI-33720
Correspondent Contact MARI RUOTSALAINEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/19/2008
Decision Date 06/18/2008
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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