LACEY PRESS-FIT CONDYLAR TOTAL KNEE

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

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Lacey Press-fit Condylar Total Knee.

Pre-market Notification Details

Device IDK864518
510k NumberK864518
Device Name:LACEY PRESS-FIT CONDYLAR TOTAL KNEE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactSpires, Jr
CorrespondentSpires, Jr
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-17
Decision Date1987-03-04

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