E1 ANTIOXIDANT INFUSED TECHNOLOGY

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for E1 Antioxidant Infused Technology.

Pre-market Notification Details

Device IDK100048
510k NumberK100048
Device Name:E1 ANTIOXIDANT INFUSED TECHNOLOGY
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeOIY  
Subsequent Product CodeJDI
Subsequent Product CodeJWH
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeMAY
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-08
Decision Date2010-03-09
Summary:summary

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