LATITUDE EV™ Total Elbow Arthroplasty

Prosthesis, Elbow, Semi-constrained, Cemented

Tornier Inc.

The following data is part of a premarket notification filed by Tornier Inc. with the FDA for Latitude Ev™ Total Elbow Arthroplasty.

Pre-market Notification Details

Device IDK193247
510k NumberK193247
Device Name:LATITUDE EV™ Total Elbow Arthroplasty
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant Tornier Inc. 10801 Nesbitt Ave South Bloomington,  MN  55347
ContactRenee Stoffel
CorrespondentRenee Stoffel
Tornier Inc. 10801 Nesbitt Ave South Bloomington,  MN  55347
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-08-05

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