Medacta International SA / Quality / Regulatory / K131458 Trade / Compliance Medacta USA / DEVICE INFORMATION Trade / /
Event
FDA Phase / / /
IndustryTerm
Internet address httn /
Organization
Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Small Manufacturers / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance / FDA / Division of Orthopedic Devices / HUMAN SERVICES PublicHealth Service / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / /
Person
Elizabeth L.Frank / Adam Gross / Mark N. Melkerson / / /
Position
Director / femoral head / ball head / /
Product
Federal Food / K1 / /
ProvinceOrState
Maryland / California / /
Technology
design verification / radiation / fundamental scientific technology / /
K1[removed]pg[removed]Medacta international 510(k) Summary Applicant/Sponsor: Medacta International SA