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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 K070369
Device Name REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
Applicant
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact ROBERT FRIDDLE
Correspondent
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact ROBERT FRIDDLE
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDG   JDI   KWZ   LWJ   LZO  
MAY   MBL   MEH  
Date Received02/08/2007
Decision Date 03/09/2007
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
Recalls CDRH Recalls
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