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510(k) K053417

M-COR HIP REPLACEMENT SYSTEM by Portland Orthopaedics Pty. , Ltd. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2006
Date Received
December 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Portland Orthopaedics Pty. , Ltd.

  • K061564 — PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD (September 1, 2006)
  • K051844 — EQUATOR PLUS ACETABULAR CUP SYSTEM (October 7, 2005)
  • K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (January 20, 2004)
  • K992815 — THE MARGRON HIP REPLACEMENT SYSTEM (February 7, 2000)

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