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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K032641
Device Name MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
Applicant
PORTLAND ORTHOPAEDICS PTY. LTD.
3/44 MCCAULEY ST.
MATRAVILLE NSW,  AU 2036
Applicant Contact DAVID SEKEL
Correspondent
PORTLAND ORTHOPAEDICS PTY. LTD.
3/44 MCCAULEY ST.
MATRAVILLE NSW,  AU 2036
Correspondent Contact DAVID SEKEL
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LPH  
Date Received08/27/2003
Decision Date 01/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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