POLY INSERT 20 DEGREE

Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Poly Insert 20 Degree.

Pre-market Notification Details

Device IDK920929
510k NumberK920929
Device Name:POLY INSERT 20 DEGREE
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactKim Tompkins
CorrespondentKim Tompkins
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeJDL  
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-28
Decision Date1993-05-05

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