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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
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