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510(k) K090705

BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT by Ortho Development Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
March 17, 2009
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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