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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 K921277
FOIA Releasable 510(k) K921277
Device Name RANAWAT/BURSTEIN TOTAL HIP SYSTEM
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA BERES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/17/1992
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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