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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 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact ROBERT FRIDDLE
Correspondent
BIOMET, INC.
56 EAST 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
Recalls CDRH Recalls
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