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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 K971890
Device Name RECOVERY PROTRUSIO CAGE
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact DEBORAH M MATARAZZO
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact DEBORAH M MATARAZZO
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/22/1997
Decision Date 08/07/1997
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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