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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K083447
Device Name MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
Applicant
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR 35170
Applicant Contact GILLES AUDIC
Correspondent
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR 35170
Correspondent Contact GILLES AUDIC
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/21/2008
Decision Date 02/06/2009
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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