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510(k) K080199

SYMMETRIC TOTAL KNEE SYSTEM by Signal Medical Corporation — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2008
Date Received
January 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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