510(k) K001984

PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT by Stelkast Company — Product Code JDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2000
Date Received
June 29, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type