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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, Cemented
510(k) Number K020076
Device Name PATRIOT PROTRUSIO CAGE
Applicant
BIOMET ORTHOPEDICS, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact TRACY J BICKEL
Correspondent
BIOMET ORTHOPEDICS, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact TRACY J BICKEL
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/09/2002
Decision Date 01/30/2002
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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