ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Ascent Porous Open Box Ps Component/ascent Posterior Stabalized (ps) Distal Femoral Pegs.

Pre-market Notification Details

Device IDK041872
510k NumberK041872
Device Name:ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-09
Decision Date2004-09-08
Summary:summary

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