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510(k) K051995

PROFEMUR RENAISSANCE HIP STEM by Wrightmedicaltechnologyinc — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 25, 2005
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

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