CLARIFIED APPLICA. FOR LACEY 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 Clarified Applica. For Lacey Condylar Total Knee.

Pre-market Notification Details

Device IDK872266
510k NumberK872266
Device Name:CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactLipscomb, Phd
CorrespondentLipscomb, Phd
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 Received1987-06-02
Decision Date1987-08-14

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