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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 K021403
Device Name HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
Applicant
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LPH  
Date Received05/02/2002
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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