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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
510(k) Number K100048
Device Name E1 ANTIOXIDANT INFUSED TECHNOLOGY
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
Correspondent Contact BECKY EARL
Regulation Number888.3560
Classification Product Code
OIY  
Subsequent Product Codes
JDI   JWH   LPH   LWJ   LZO  
MAY   OQG   OQH   OQI  
Date Received01/08/2010
Decision Date 03/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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