Stryker IBur Hubs And Cutting Accessories

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

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Ibur Hubs And Cutting Accessories.

Pre-market Notification Details

Device IDK210377
510k NumberK210377
Device Name:Stryker IBur Hubs And Cutting Accessories
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant Stryker Corporation 1941 Stryker Way Portage,  MI  49002
ContactAlison Garrad
CorrespondentAlison Garrad
Stryker 1941 Stryker Way Portage,  MI  49002
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-06-30

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