Exeter V40 Femoral Stem, Exeter X3 RimFit Cup

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Howmedica Osteonics Corp

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Exeter V40 Femoral Stem, Exeter X3 Rimfit Cup.

Pre-market Notification Details

Device IDK193429
510k NumberK193429
Device Name:Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant Howmedica Osteonics Corp 325 Corporate Drive Mahwah,  NJ  07430
ContactAlexandra Kirby
CorrespondentAlexandra Kirby
Howmedica Osteonics Corp 325 Corporate Drive Mahwah,  NJ  07430
Product CodeJDI  
Subsequent Product CodeJDG
Subsequent Product CodeKWY
Subsequent Product CodeLZO
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-10
Decision Date2020-08-13

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