VANGUARD REMOVABLE MOLDED POLY TIBIA

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Removable Molded Poly Tibia.

Pre-market Notification Details

Device IDK102580
510k NumberK102580
Device Name:VANGUARD REMOVABLE MOLDED POLY TIBIA
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46580
ContactTamara J West
CorrespondentTamara J West
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46580
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-08
Decision Date2011-03-03
Summary:summary

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