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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 K063614
Device Name ALTRA FX HIP SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw,  IN  46581 -0587
Applicant Contact becky earl
Correspondent
BIOMET MANUFACTURING CORP.
po box 587
warsaw,  IN  46581 -0587
Correspodent Contact becky earl
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LPH   LWJ   LZO   MAY   MEH  
Date Received12/05/2006
Decision Date 02/20/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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