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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 K070039
Device Name MEMOMETAL FIXOS SCREWS
Applicant
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR F35170
Applicant Contact GILLES AUDIC
Correspondent
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR F35170
Correspondent Contact GILLES AUDIC
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/03/2007
Decision Date 03/21/2007
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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