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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 Uncemented Acetabular Component)
510(k) Number K093235
Device Name RINGLOC + HYBRID ACETABULAR SYSTEM
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LPH   LZO  
Date Received10/15/2009
Decision Date 04/30/2010
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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