510(k) K072704

UNICOMPARTMENTAL KNEE by Valpo Orthopedic Technology, Inc. — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2008
Date Received
September 24, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type