WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM

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 M.a. Total Knee System.

Pre-market Notification Details

Device IDK893252
510k NumberK893252
Device Name:WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactDiane Deere
CorrespondentDiane Deere
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 Received1989-04-28
Decision Date1989-07-28

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