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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 K032167
Device Name BIO-INTRAFIX TIBIAL SCREW AND SHEATH
Applicant
Mitek Worldwide
A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact KAREN K SYLVIA
Correspondent
Mitek Worldwide
A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact KAREN K SYLVIA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/16/2003
Decision Date 10/15/2003
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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