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510(k) K103837

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA by Ortho Development — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2011
Date Received
December 30, 2010
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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