WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP

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 Whiteside Ortholoc Mod.tibial Augmentation Comp.

Pre-market Notification Details

Device IDK914169
510k NumberK914169
Device Name:WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactDiane Patton
CorrespondentDiane Patton
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-17
Decision Date1992-01-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.