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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
Recalls CDRH Recalls
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