Salto XT, Salto Talaris

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

Tornier SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Salto Xt, Salto Talaris.

Pre-market Notification Details

Device IDK153452
510k NumberK153452
Device Name:Salto XT, Salto Talaris
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant Tornier SAS 161 Rue Lavoisier Montbonnot St. Martin,  FR 38330
ContactSéverine Bonneton
CorrespondentSéverine Bonneton
Tornier SAS 161 Rue Lavoisier Montbonnot St. Martin,  FR 38330
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-30
Decision Date2016-08-11
Summary:summary

NIH GUDID Devices

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