510(k) K061844

DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER by Wrightmedicaltechnologyinc — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2006
Date Received
June 29, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type