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510(k) K061564

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD by Portland Orthopaedics Pty. , Ltd. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2006
Date Received
June 5, 2006
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

Other clearances by Portland Orthopaedics Pty. , Ltd.

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  • K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (January 20, 2004)
  • K992815 — THE MARGRON HIP REPLACEMENT SYSTEM (February 7, 2000)

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