CERAMIC FEMORAL HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ceramic Femoral Head.

Pre-market Notification Details

Device IDK893685
510k NumberK893685
Device Name:CERAMIC FEMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-16
Decision Date1989-09-26

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