Stryker Footed Attachments And Cutting Accessories

Drills, Burrs, Trephines & Accessories (simple, Powered)

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Footed Attachments And Cutting Accessories.

Pre-market Notification Details

Device IDK143399
510k NumberK143399
Device Name:Stryker Footed Attachments And Cutting Accessories
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49002
ContactVishal Kanani
CorrespondentVishal Kanani
STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49002
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-28
Decision Date2015-05-08
Summary:summary

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