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510(k) K032824

STELKAST UNICONDYLAR KNEE SYSTEM by Stelkast Company — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2003
Date Received
September 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

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  • K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SY (August 5, 2013)
  • K122773 — CROSS-OVER ACETABULAR SHELL & LINER (October 9, 2012)
  • K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (March 24, 2011)
  • K081458 — PROVEN STEM EXTENDER (June 6, 2008)
  • K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (January 18, 2007)
  • K051976 — PROVEN REVISION MODULAR TIBIAL TRAY (October 17, 2005)
  • K033944 — STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (March 12, 2004)

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