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510(k) K063211

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT by Stelkast Company — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2007
Date Received
October 23, 2006
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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  • K081458 — PROVEN STEM EXTENDER (June 6, 2008)
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  • K033944 — STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (March 12, 2004)
  • K032824 — STELKAST UNICONDYLAR KNEE SYSTEM (November 13, 2003)

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