ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ultra High Molecular Weight Polyethylene Component.

Pre-market Notification Details

Device IDK921182
510k NumberK921182
Device Name:ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactPatricia Beres
CorrespondentPatricia Beres
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-10
Decision Date1993-07-23

NIH GUDID Devices

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