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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
Recalls CDRH Recalls
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