LATITUDE ELBOW PROTHESIS

Prosthesis, Elbow, Semi-constrained, Cemented

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Latitude Elbow Prothesis.

Pre-market Notification Details

Device IDK070787
510k NumberK070787
Device Name:LATITUDE ELBOW PROTHESIS
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex,  FR 38334
ContactMireille Lemery
CorrespondentMireille Lemery
TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex,  FR 38334
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-22
Decision Date2007-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846832012473 K070787 000
00846832012466 K070787 000
00846832012459 K070787 000

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