Stryker Universal Mesh

Plate, Bone

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 IDK170773
510k NumberK170773
Device Name:Stryker Universal Mesh
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-14
Decision Date2017-11-08
Summary:summary

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