EVOLUTION HIP SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Evolution Hip System.

Pre-market Notification Details

Device IDK896105
510k NumberK896105
Device Name:EVOLUTION HIP SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactMicki Roy
CorrespondentMicki Roy
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-20
Decision Date1989-12-29

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