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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 uncemented acetabular component)
510(k) Number K042037
Device Name M2A MAGNUM SYSTEM
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact KACY ARNOLD
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact KACY ARNOLD
Regulation Number888.3330
Classification Product Code
KWA  
Date Received07/29/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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