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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 K992815
Device Name THE MARGRON HIP REPLACEMENT SYSTEM
Applicant
PORTLAND ORTHOPAEDICS PTY. LTD.
SUITE 3 LEVEL 5 ST. GEORGE
PRIVATE HOSPITAL 1 SOUTH ST.
KOGARAH, NEW SOUTH WALES,  AU NSW 2217
Applicant Contact RONALD SEKEL
Correspondent
PORTLAND ORTHOPAEDICS PTY. LTD.
SUITE 3 LEVEL 5 ST. GEORGE
PRIVATE HOSPITAL 1 SOUTH ST.
KOGARAH, NEW SOUTH WALES,  AU NSW 2217
Correspondent Contact RONALD SEKEL
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LPH  
Date Received08/20/1999
Decision Date 02/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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