POROUS-COATED TITANIUM ACETABULAR CUP

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 Porous-coated Titanium Acetabular Cup.

Pre-market Notification Details

Device IDK894965
510k NumberK894965
Device Name:POROUS-COATED TITANIUM ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
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 CodeJDL  
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-07
Decision Date1989-11-17

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