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510(k) K992815

THE MARGRON HIP REPLACEMENT SYSTEM by Portland Orthopaedics Pty. , Ltd. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2000
Date Received
August 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Portland Orthopaedics Pty. , Ltd.

  • K061564 — PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD (September 1, 2006)
  • K053417 — M-COR HIP REPLACEMENT SYSTEM (July 20, 2006)
  • K051844 — EQUATOR PLUS ACETABULAR CUP SYSTEM (October 7, 2005)
  • K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (January 20, 2004)

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