FDA.report

510(k) K082924

Device
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) number
K082924
Product code
KWA  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-06
Date received
2008-10-01
Regulation
888.3330
Classification name
Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
3
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MATT PAUL
Address
5677 Airline Rd. Arlington TN US 38002 38002

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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