Number K042021 Trade / K 121067 Trade / Exacteche Incorporated / K102951 Equinoxe Fixed Angle Replicator Plates Exactech Inc. / Exactech / /
Event
FDA Phase / /
Facility
Court Gainesville / / /
IndustryTerm
press-fit applications / metal/polymer / cemented and press-fit applications / announcements concerning your device / predicate devices / Internet address http /
Organization
Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / IL IF / Division Sign-Om20 Division of Orthopedic Devices / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / New Hamrpshire Avenue Documnent Conrolv Center / Device Evaluation Center for Devices / Mark N. Melkerson Mark N. Melkerson Director Division / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /
Person
Mark N. Melkerson / Graham L. Cuthbert / / /
Position
orthopaedic surgeon / humeral head / humneral head / surgeon / Regulatory Affairs Specialist / Regulator Affairs Specialist / /
1(12/Zcc?7 ( (AJ) Exactech® Equinoxe® Shoulder System Replicator Plates Special 510(k[removed]k) Summary of Safety and Effectiveness DEC[removed]