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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, Metal/Polymer, Porous Uncemented
510(k) Number K031693
Device Name MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
Applicant
BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received06/02/2003
Decision Date 08/06/2003
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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