UNITY HUMERAL PLATE

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Unity Humeral Plate.

Pre-market Notification Details

Device IDK060545
510k NumberK060545
Device Name:UNITY HUMERAL PLATE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant TORNIER RUE DOYEN GOSSE St. Ismier,  FR 38330
ContactMireille Lemery
CorrespondentMireille Lemery
TORNIER RUE DOYEN GOSSE St. Ismier,  FR 38330
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-01
Decision Date2006-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700386928819 K060545 000

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