MP LeFort I Plates

Plate, Bone

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Mp Lefort I Plates.

Pre-market Notification Details

Device IDK171364
510k NumberK171364
Device Name:MP LeFort I Plates
ClassificationPlate, Bone
Applicant Stryker 750 Trade Centre Way Suite 200 Portage,  MI  49002
ContactGregory Gohl
CorrespondentGregory Gohl
Stryker 750 Trade Centre Way Suite 200 Portage,  MI  49002
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-09
Decision Date2017-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327359848 K171364 000
07613327359701 K171364 000
07613327359718 K171364 000
07613327359725 K171364 000
07613327359763 K171364 000
07613327359787 K171364 000
07613327359794 K171364 000
07613327359800 K171364 000
07613327359817 K171364 000
07613327359671 K171364 000

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