TORNIER CEMENT RESTRICTOR

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

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Cement Restrictor.

Pre-market Notification Details

Device IDK001932
510k NumberK001932
Device Name:TORNIER CEMENT RESTRICTOR
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-26
Decision Date2000-07-20

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