Exactech Inc. / Numbe Trade / K111379 Trade / Degree Posterior Augment Pegged Glenoid Exactech Inc. / /
Event
FDA Phase / /
Facility
Court Gainesville / / /
IndustryTerm
press-fit applications / cemented and press-fit applications / Internet address h-ttp /
Organization
Division of Postmarket Surveillance / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / Device Evaluation Center for Devices and Radiological Health Enclosure c/ K1113'/ / office of Device Evaluation / FDA / Division of Surgical / Orthopedic / and Restorative Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic / and Restorative Devices Office / Mark N. Melkerson Director/ Division of Surgical / /
Person
Grahamn Cuthbert / Mark N. Melkerson / Rheumatoid / Graham Cuthbert / / /
Exactech® Equinoxe® UHMWPE 12* Posterior Augment Pegged GlenoidsrM Special 510(k[removed]k) Summary of Safety and Effectiveness 1. Sponsor: Exactech® Inc[removed]N.W. 6 6I1h Court