K132554 Trade / Synthes / lmplantate AG Company / Implantate AG / Impiantate AG / /
Country
United States / /
Event
FDA Phase / / /
IndustryTerm
announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
Organization
Orthopedic Devices Office / Division of Urtflopedic Vevices Page / Division of Small Manufacturers / Division of Postimarket Surveillance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / CDRH's office of Surveillance / /
Person
Elizabeth L.Frank / Christian Zietsch Lorenzweg / Christian Zietsch / Christian Zielseb / Mark N. Melkerson / Zietsch Lorenzweg / / /
Position
small head / Manager Regulatory Affairs Lorenzweg / surgeon / /
Product
Titanium LOP Proximal Tibia Plating System / Federal Food / K050646 / K023802 / /
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