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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 K101254
Device Name NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
Applicant
Tecnologia Y Diseno Industrial, S.A DE C.V
P.O. Box 506
South Lyon,  MI 
Applicant Contact ROBERT J BARD, JD
Correspondent
Tecnologia Y Diseno Industrial, S.A DE C.V
P.O. Box 506
South Lyon,  MI 
Correspondent Contact ROBERT J BARD, JD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/04/2010
Decision Date 07/15/2010
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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