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510(k) K033944

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD by Stelkast Company — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2004
Date Received
December 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • K032824 — STELKAST UNICONDYLAR KNEE SYSTEM (November 13, 2003)

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