Stryker Universal Mesh

Plate, Cranioplasty, Preformed, Alterable

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Mesh.

Pre-market Notification Details

Device IDK161821
510k NumberK161821
Device Name:Stryker Universal Mesh
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant Stryker 750 Trade Centre Way - Suite 200 Portage,  MI  49002
ContactJonathan Schell
CorrespondentJonathan Schell
Stryker 750 Trade Centre Way - Suite 200 Portage,  MI  49002
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-01
Decision Date2016-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327459500 K161821 000
07613327123036 K161821 000
07613327123012 K161821 000
07613327123005 K161821 000
07613327122985 K161821 000
07613327122954 K161821 000
07613327122947 K161821 000
07613327122930 K161821 000
07613327122923 K161821 000
07613327122916 K161821 000
07613327122909 K161821 000
07613327122886 K161821 000
07613327122879 K161821 000
07613327635119 K161821 000
07613327123043 K161821 000
07613327123050 K161821 000
07613327123074 K161821 000
07613327123333 K161821 000
07613327123326 K161821 000
07613327123258 K161821 000
07613327123203 K161821 000
07613327123197 K161821 000
07613327123180 K161821 000
07613327123166 K161821 000
07613327123159 K161821 000
07613327123128 K161821 000
07613327123111 K161821 000
07613327123104 K161821 000
07613327123098 K161821 000
07613327123081 K161821 000
07613327635102 K161821 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.