K123924 Trade / DePuy / Submitter Information DePuy Orthopaedics Inc. / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
subject device / acetabular cup using bone cement / Internet address http /
Organization
Orthopedic Devices Office / Anton E. DiiiitiihvPhD Division of Orthtoidi~tDevices / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / CDRH's office of Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Section / /
Person
Silver Spring / Correne Rainy / Mark N. Melkerson / / /
K123924 (Page 1 of 3) Section 5: 510 (k) Summary MAR[removed]As required by 21 CER[removed]and 21 CFR[removed])