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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 K090757
Device Name BIOMET MODULAR FEMORAL REVISION SYSTEM
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
warsaw,  IN  46581 -0587
Applicant Contact becky earl
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
warsaw,  IN  46581 -0587
Correspondent Contact becky earl
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWY   KWZ   LPH  
LZO   MAY   MEH  
Date Received03/23/2009
Decision Date 09/25/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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